FDA 510(k) Applications Submitted by Monica E. Giguere

FDA 510(k) Number Submission Date Device Name Applicant
K001364 05/01/2000 BD DIRECTIGEN FLU A+B BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K051689 06/23/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML BECTON, DICKINSON & CO.
K061869 07/03/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML BECTON, DICKINSON & CO.
K052270 08/19/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML BECTON, DICKINSON & CO.
K052269 08/19/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN BECTON, DICKINSON & CO.
K073589 12/20/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO.
K050089 01/14/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML BECTON, DICKINSON & CO.
K040099 01/20/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K060218 01/27/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML BECTON, DICKINSON & CO.
K060217 01/27/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML BECTON DICKINSON & CO.
K060214 01/27/2006 BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML BECTON, DICKINSON & CO.
K060257 02/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML BECTON, DICKINSON & CO.
K060324 02/09/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE BECTON DICKINSON & CO.
K050400 02/16/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML BECTON, DICKINSON & CO.
K060447 02/21/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) BECTON DICKINSON & CO.
K060444 02/21/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML BECTON, DICKINSON & CO.
K140468 02/25/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) Becton, Dickinson and Company
K060558 03/02/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML BECTON, DICKINSON & CO.
K050555 03/03/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML BECTON, DICKINSON & CO.
K040716 03/19/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML BECTON, DICKINSON & CO.
K050745 03/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML BECTON, DICKINSON & CO.
K050747 03/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML BECTON, DICKINSON & CO.
K070809 03/26/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML BECTON, DICKINSON & CO.
K030986 03/28/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML BECTON, DICKINSON & CO.
K050865 04/05/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML BECTON, DICKINSON & CO.
K050946 04/15/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML BECTON, DICKINSON & CO.
K050982 04/19/2005 BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) BECTON, DICKINSON & CO.
K051138 05/04/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML BECTON, DICKINSON & CO.
K051183 05/09/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML BECTON, DICKINSON & CO.
K131331 05/09/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) BECTON, DICKINSON & CO.
K051204 05/11/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML BECTON, DICKINSON & CO.
K051266 05/16/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML BECTON, DICKINSON & CO.
K051272 05/17/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML BECTON, DICKINSON & CO.
K021954 06/14/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML BECTON, DICKINSON & CO.
K041572 06/14/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML BECTON, DICKINSON AND CO.
K051692 06/23/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML BECTON, DICKINSON & CO.
K031943 06/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML BECTON, DICKINSON & CO.
K032131 07/11/2003 BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO.
K142170 08/07/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP Becton, Dickinson and Company
K052250 08/18/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML BECTON, DICKINSON & CO.
K992849 08/24/1999 QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K132674 08/27/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) Becton, Dickinson and Company
K032675 08/29/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML BECTON, DICKINSON & CO.
K082538 09/02/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST BECTON, DICKINSON & CO.
K023301 10/03/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON DICKINSON & CO.
K123266 10/19/2012 BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN Becton, Dickinson and Company
K993577 10/21/1999 CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC BECTON DICKINSON MICROBIOLOGY SYSTEMS
K042932 10/22/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML BECTON, DICKINSON & CO.
K023568 10/24/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K033458 10/30/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST BECTON, DICKINSON & CO.
K063486 11/17/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY BECTON, DICKINSON & CO.
K053241 11/18/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML BECTON, DICKINSON & CO.
K043389 12/09/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML BECTON, DICKINSON & CO.
K043458 12/15/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML BECTON, DICKINSON & CO.
K151320 05/18/2015 BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml BECTON, DICKINSON AND COMPANY
K181665 06/25/2018 BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN Becton,Dickinson and Company
K173523 11/14/2017 BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) Becton, Dickinson and Company
K163637 12/23/2016 BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) BECTON, DICKINSON & COMPANY
K031530 05/15/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML BECTON DICKINSON & CO.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact