510(k) Report

Devices descending from K020321

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+2K233986BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)Becton, Dickinson and Company20240—
+2K181665BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company201802
+2K082140Xpert Mrsa/SA Blood Culture AssayCepheid200832
+2K080837Xpert Mrsa/SA Ssti AssayCepheid20081—
+2K073589BD Phoenix Automated Microbiology System-Daptomycin (0.0313-16 UG/ML) Steptococcus…Becton, Dickinson & CO20080—
+2K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc)20079—
+2K070346Dade Behring Labpro Alert Software SystemDade Behring, Inc.20071—
+3K243625Xpert MRSA/SA SSTICepheid®20240—
+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—