510(k) Report

Devices descending from K020322

118 later devices reach BD Phoenix Automated Microbiology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082852BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128 UG/MLBecton, Dickinson & CO20090—
+1K082913BD Phoenix Automated Microbiology System-Doxycycline (GP) 0.25-16 UG/MLBecton, Dickinson & CO20080—
+1K082538BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance TestBecton, Dickinson & CO200801
+1K082140Xpert Mrsa/SA Blood Culture AssayCepheid200832
+1K080837Xpert Mrsa/SA Ssti AssayCepheid20081—
+1K073589BD Phoenix Automated Microbiology System-Daptomycin (0.0313-16 UG/ML) Steptococcus…Becton, Dickinson & CO20080—
+1K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc)20079—
+1K070809BD Phoenix Automated Microbiology System-Minocycline (GP) 1-32 UG/MLBecton, Dickinson & CO200702
+1K063486BD Phoenix Automated Microbiology System Minocycline (1-32 UG/ML) Gram Negative ID/Ast…Becton, Dickinson & CO20070—
+1K063824BD Phoenix Automated Microbiology System - Aztreonam (GN) 0.5-64UG/MLBecton, Dickinson & CO20070—
+1K063811BD Phoenix Automated Microbiology System - Cefazolin (GN) 0.5-32UG/MLBecton, Dickinson & CO20070—
+1K063300BD Phoenix Automated Microbiology System - Cefpodoxime (GN) 0.125-8UG/MLBecton, Dickinson & CO20070—
+1K063301BD Phoenix Automated Microbiology System - Cefepime (GN) 0.5-64UG/MLBecton, Dickinson & CO20060—
+1K062945BD Phoenix Automated Microbiology System - Ertapenem (GN) 0.25-32 UG/MLBecton, Dickinson & CO20060—
+1K062687BD Phoenix Automated Microbiology Systen - Ticarcillin-Clavulanate (GN) 1/2 - 128/2UG/MLBecton, Dickinson & CO20060—
+1K062206BD Phoenix Automated Microbiology System - Moxifloxacin (Strep) 0.0625 - 8UG/MLBecton, Dickinson & CO20060—
+1K061869BD Phoenix Automated Microbiology System-Piperacillin-Tazobactam (GP) 1/4-128/4 UG/MLBecton, Dickinson & CO20060—
+1K061867BD Phoenix Automated Microbiology System-Cefazolin (GN) 0.5-32 UG/MLBecton, Dickinson & CO20061—
+1K061673BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GP) 0.25/0.12 -32/16…Becton, Dickinson & CO20060—
+1K060324BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent…Becton, Dickinson & CO200611—
+1K060558BD Phoenix Automated Microbiology System Cephalothin - GN 1 - 64 UG/MLBecton, Dickinson & CO20060—
+1K060493BD Phoenix Automated Microbiology System - Vancomycin-GP Detection of Vrsa.Becton, Dickinson & CO20060—
+1K060214BD Phoenix Automated Mircrobiology System Tetracycline-GN 0.5-16 UG/ML and GP 0.5-16 UG/MLBecton, Dickinson & CO20060—
+1K053241BD Phoenix Automated Microbiology System - Cefoxitin GP 1-32 G/MLBecton, Dickinson & CO20050—
+1K052270BD Phoenix Automated Microbiology System - Cefuroxime (Strep) 0.125 - 4UG/MLBecton, Dickinson & CO20050—
+1K052269BD Phoenix Automated Microbiology System -Ciprofloxacin GNBecton, Dickinson & CO20052—
+1K052250BD Phoenix Automated Microbiology System - Tobramycin (GP) 0.5-16UG/MLBecton, Dickinson & CO20050—
+1K051689BD Phoenix Automated Microbiology System - Daptomycin 0.125 - 32 UG/MLBecton, Dickinson & CO20050—
+1K051692BD Phoenix Automated Microbiology System - Amoxicillin (Strep) 0.0313 - 32 UG/MLBecton, Dickinson & CO20050—
+1K051272BD Phoenix Automated Microbiology System - Clindamycin (Strep) 0.03125 -4 UG/MLBecton, Dickinson & CO20050—
+1K051266BD Phoenix Automated Microbiology System - Linezolid (Strep) 0.25 - 16UG/MLBecton, Dickinson & CO20050—
+1K051204BD Phoenix Automated Microbiology System Cefepime (Strep) 0.0625-4UG/MLBecton, Dickinson & CO20050—
+1K051109BD Phoenix Automated Microbiology System - Erythromycin (Strep) 0.0156 - 4UG/MLBecton, Dickinson & CO20050—
+1K051138BD Phoenix Automated Microbiology System - Ceftriaxone (Strep) 0.0625 - 4UG/MLBecton, Dickinson & CO20050—
+1K050946BD Phoenix Automated Microbiology System-Meropenem (Strep) 0.03125-2 UG/MLBecton, Dickinson & CO20050—
+1K050982BD Phonix Automated Microbiology System - Cefotaxime Strep (0.0625-4UG/ML)Becton, Dickinson & CO20050—
+1K050865BD Phoenix Automated Microbiology System-Trimethoprim-Sulfamethoxazole 0.0625/1.2-16/304…Becton, Dickinson & CO20050—
+1K050881BD Phoenix Automated Microbiology System - Tetracycline (Strep) 0.0625 - 16 UG/MLBecton, Dickinson & CO20050—
+1K050780BD Phoenixtm Automated Microbiology System - Penicillin (Strep) 0.156 -32 UG/MLBecton, Dickinson & CO20050—
+1K050745BD Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 UG/MLBecton, Dickinson & CO200503
+1K050747BD Phoenix Automated Microbiology System, Levofloxacin (Strep) 0.25-16 UG/MLBecton, Dickinson & CO20050—
+1K050555BD Phoenix Automated Microbiology System - Cefazolin (GP) 2-32 UG/MLBecton, Dickinson & CO20050—
+1K050400BD Phoenix Automated Microbiology System - Cephalothin (GP) 0.5-64 UG/MLBecton, Dickinson & CO200501
+1K043458BD Phoenix Automated Microbiology System - Cefotetan (GN) 2-64 UG/MLBecton, Dickinson & CO20050—
+1K050089BD Phoenix Automated Microbiology System - Ampicillin-Sulbactam (GP) 2-32 UG/MLBecton, Dickinson & CO20050—
+1K043389BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/MLBecton, Dickinson & CO20053—
+1K042932BD Phoenix Automated Microbiology System-Piperacillin-Tazobactam 0.5/4-128/4 UG/MLBecton, Dickinson & CO20040—
+1K041572BD Phoenix Automated Microbiology System-Pipercillin (GN) 0.5-128 UG/MLBecton, Dickinson and Co.20041—
+1K041384BD Phoenix Automated Microbiology System - Ceftazidime - Gram NegativeBecton, Dickinson & CO20041—
+1K033458BD Phoenix Automated Microbiology System - Confirmatory Esbl TestBecton, Dickinson & CO200411
+1K040716BD Phoenix Automated Microbiology System-Penicillin (GP) 0.0625-32 UG/MLBecton, Dickinson & CO20040—
+1K033907BD Phoenix Automated Microbiology System - Trimethoprim-Sulfamethoxazole 0.5/9.5 -…Becton, Dickinson & CO20041—
+1K033362BD Phoenix Automated Microbiology System- Cefuroxime Gram NegativeBecton, Dickinson & CO20041—
+1K040099BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO200424
+1K040106BD Phoenix Automated Microbiology System -- Ampicillin -- Gram PositiveBecton, Dickinson & CO20040—
+1K032675BD Phoenix Automated Microbiology System-Cefepime (GN) 0.5-65 UG/MLBecton, Dickinson & CO20043—
+1K040006BD Phoenix Automated Microbiology System-Linezolid-Gram PositiveBecton, Dickinson & CO20040—
+1K033784BD Phoenix Automated Microbiology System - Erythromycin 0.0625-8 UG/MLBecton, Dickinson & CO20041—
+1K033889BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent…Becton, Dickinson & CO20041—
+1K033557BD Phoenix Automated Microbiology System - Ticarcillin/Clavulanate-Gram NegativeBecton, Dickinson & CO20041—
+1K033560BD Phoenix Automated Microbiology System - Ceftazidime 0.5-64 UG/ML-Gram-Negative ID/Ast…Becton, Dickinson & CO20042—
+1K033558BD Phoenix Automated Microbiology System - Aztreonam 0.5-64 UG/ML-Gram-Negative ID/Ast…Becton, Dickinson & CO20031—
+1K032655BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 UG/MLBecton, Dickinson & CO20033—
+1K032275BD Phoenix Automated Microbiology System-Imipenem 1-16 UG/ML Gram-Negative ID/Ast or Ast…Becton, Dickinson & CO20030—
+1K032299BD Phoenix Automated Microbiology System,-Ampicillin 0.5.-32 UG/MLBecton, Dickinson & CO20031—
+1K032567BD Phoenix Automated Microbiology System-Cefoxitin-Gram NegativeBecton, Dickinson & CO20031—
+1K032153BD Phoenix Automated Microbiology System Cefotaxime 0.5-64 UG/MLBd Diagnostic Systems20030—
+1K031984BD Phoenix Automated Microbiology System-Ticarcillin-1-128 UG/MLBecton, Dickinson & CO20033—
+1K032131BD Automated Microbiology System Tetracycline - GP 0.5-16 UG/ML-Gram Positive ID/Ast or…Becton, Dickinson & CO20031—
+1K031943BD Phoenix Automated Microbiology System - Cephalothin (GN) 1-64 UG/MLBecton, Dickinson & CO20031—
+1K031699BD Phoenix Automated Microbiology System - Trimethoprim-Sulfamethoxazole…Becton, Dickinson & CO20030—
+1K031912BD Phoenix Automated Micrbiology System Amoxicillin/Clavualante 0.5/0.25-32/16 UG/MLBecton, Dickinson & CO20033—
+1K031679BD Phonenix Automated Microbiology SystemBecton, Dickinson & CO20030—
+1K031589BD Phoenix Automated Microbiology System-Nitrofurantoin Gram PositiveBecton, Dickinson & CO20031—
+1K031530BD Phoenix Automated Microbiology System-Nitrofurantoin-8-512 UG/MLBecton, Dickinson & CO20031—
+1K031429BD Phoenix Automated Microbiology System-Meropenem 0.25-16 UG/MLBd Diagnostic Systems20030—
+1K031306BD Phoenix Automated Microbiology System - Moxifloxacin Gram PositiveBecton, Dickinson & CO20032—
+1K030986BD Phoenix Automated Microbiology System Trimethoprim - GN 0.5-16 UG/MLBecton, Dickinson & CO20030—
+1K030677BD Phoenix Automated Microbiology System-Vancomycin Gram PositiveBecton, Dickinson & CO200312
+1K030579BD Phoenix Automated Microbiology System-Nalidixic Acid - 2-32 UG/MLBecton, Dickinson & CO20031—
+1K030091BD Phoenix Automated Microbiology System - Norfloxacin 0.25 - 16 UG/MLBd Diagnostic Systems20030—
+1K024153BD Phoenix Automated Microbiology System - Tetracycline - 0.5-16 UG/MLBecton, Dickinson & CO20031—
+1K024152BD Phoenix Automated Microbiology System - Rifampin 0.25-32 UG/MLBecton, Dickinson & CO20030—
+1K023568BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO20030—
+1K023895BD Phoenix Automated Microbiology System - Ciprofloxacin GNBecton, Dickinson & CO20030—
+1K023634BD Phoenix Automated Microbiology System-Gentamicin GN (0.25-16UG/ML)Becton, Dickinson & CO20020—
+1K023527BD Phoenix Automated Microbiology System - Norfloxacin - 0.25-16 UG/MLBecton, Dickinson & CO20020—
+1K023858BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO20020—
+1K023301BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO2002102
+1K023444BD Phoenix Automated Microbiology System-Amikacin-0.5-64 UG/MLBecton, Dickinson & CO20020—
+1K023273BD Phoenix Automated Microbiology System - Gentamicin 0.25 - 16 UG/MLBecton, Dickinson & CO20020—
+1K022172BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO20021—
+1K021954BD Phoenix Automated Microbiology System-Clindamycin 0.125-8.0MCG/MLBecton, Dickinson & CO200201
+1K022129BD Phoenix Automated Microbiology System Moxifloxacin 0.125-8 UG/MLBecton, Dickinson & CO20020—
+2K243625Xpert MRSA/SA SSTICepheid®20240—
+2K181665BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company201802
+2K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+2K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid20131—
+2K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc.20111—
+2K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid201021