510(k) Report

Devices descending from K020323

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K062680BD Phoenix Automated Microbiology System - Ticarcillin (GN) 1-128 UG/MLBecton, Dickinson & CO20060—
+2K062207BD Phoenix Automated Microbiology System - Cefuroxime (GN) 1-64 UG/MLBecton, Dickinson & CO20060—
+2K061327BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN) 0.5/0.25-32/16…Becton, Dickinson & CO20062—
+2K061355BD Phoenix Automated Microbiology System - Ampicillin (GN) 0.5-32 UG/MLBecton, Dickinson & CO20060—
+2K060447BD Phoenix Automated Microbiology System -Nitrofurantoin (GN) 8-512 UG/ML…Becton, Dickinson & CO20060—
+2K060257BD Phoenix Automated Microbiology System - Cefoxitin - 0.5-64 UG/MLBecton, Dickinson & CO20060—
+2K060217BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and Ciprofloxacin-0.25 -…Becton, Dickinson & CO20061—
+2K060444BD Phoenix Automated Microbiology System - Cefepime (GN) , Ceftriaxone (GN), Cefotaxime…Becton, Dickinson & CO20062—
+2K060218BD Phoenix Automated Microbiology System - Erythromycin-0.0625-8 UG/ML, and…Becton, Dickinson & CO20060—
+3K243625Xpert MRSA/SA SSTICepheid®20240—
+3K233986BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)Becton, Dickinson and Company20240—
+3K201405LabPro Data Management SystemBeckman Coulter, Inc.202002
+3K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+3K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid20131—
+3K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc.20111—
+3K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid201021
+4K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…Cepheid20190—
+4K120563Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc.20120—