FDA 510(k) Applications Submitted by Becton, Dickinson & Co.

FDA 510(k) Number Submission Date Device Name Applicant
K031679 05/30/2003 BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K032299 07/25/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML BECTON, DICKINSON & CO.
K023444 10/15/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML BECTON, DICKINSON & CO.
K033558 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO.
K020321 01/15/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K020322 01/15/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K020323 01/15/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K052481 09/09/2005 BD VIPER SYSTEM BECTON, DICKINSON & CO.
K033861 12/12/2003 BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K023955 11/27/2002 BD VIPER INSTRUMENT BECTON, DICKINSON & CO.
K033889 12/16/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE BECTON, DICKINSON & CO.
K083572 12/03/2008 BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM BECTON, DICKINSON & CO.
K070691 03/13/2007 BBL CHROMAGAR 0157 BECTON, DICKINSON & CO.
K130268 02/04/2013 BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K042472 09/10/2004 BD DIRECTIGEN EZ FLU A + B BECTON, DICKINSON & CO.
K160161 01/27/2016 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit Becton, Dickinson & Co.
K160164 01/27/2016 BD Veritor System for Rapid Detection of Flu A + B Labratory Kit Becton, Dickinson & Co.
K061355 05/15/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML BECTON, DICKINSON & CO.
K061867 07/03/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML BECTON, DICKINSON & CO.
K062206 08/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML BECTON, DICKINSON & CO.
K062687 09/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML BECTON, DICKINSON & CO.
K062944 09/28/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML BECTON, DICKINSON & CO.
K082852 09/29/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML BECTON, DICKINSON & CO.
K063301 11/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML BECTON, DICKINSON & CO.
K063811 12/22/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML BECTON, DICKINSON & CO.
K063824 12/26/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML BECTON, DICKINSON & CO.
K014123 12/17/2001 BACTEC MGIT 960 SIRE KITS BECTON, DICKINSON & CO.
K090971 04/06/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K030579 02/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML BECTON, DICKINSON & CO.
K031699 06/02/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML BECTON, DICKINSON & CO.
K031984 06/26/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML BECTON, DICKINSON & CO.
K022129 07/01/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML BECTON, DICKINSON & CO.
K023273 10/01/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML BECTON, DICKINSON & CO.
K023527 10/21/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML BECTON, DICKINSON & CO.
K024152 12/17/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML BECTON, DICKINSON & CO.
K033907 12/17/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML BECTON, DICKINSON & CO.
K081825 06/27/2008 BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K081824 06/27/2008 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K032655 08/28/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML BECTON, DICKINSON & CO.
K052224 08/16/2005 BD PROBE TEC URINE PRESERVATIVE TRANSPORT BECTON, DICKINSON & CO.
K023858 11/20/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K040106 01/20/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE BECTON, DICKINSON & CO.
K030677 03/04/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE BECTON, DICKINSON & CO.
K031306 04/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE BECTON, DICKINSON & CO.
K021582 05/14/2002 BACTEC MGIT 960 PZA KIT BECTON, DICKINSON & CO.
K031589 05/21/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE BECTON, DICKINSON & CO.
K041384 05/25/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE BECTON, DICKINSON & CO.
K031912 06/20/2003 BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML BECTON, DICKINSON & CO.
K022172 07/03/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K032275 07/23/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO.
K032567 08/20/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE BECTON, DICKINSON & CO.
K023634 10/29/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) BECTON, DICKINSON & CO.
K033557 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE BECTON, DICKINSON & CO.
K023895 11/22/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN BECTON, DICKINSON & CO.
K024153 12/17/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML BECTON, DICKINSON & CO.
K051109 05/02/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML BECTON, DICKINSON & CO.
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.
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.
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.
K060257 02/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML BECTON, DICKINSON & CO.
K050400 02/16/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML 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.
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.
K050747 03/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML BECTON, DICKINSON & CO.
K050745 03/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 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.
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.
K052250 08/18/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML BECTON, DICKINSON & CO.
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.
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.
K123404 11/05/2012 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) BECTON, DICKINSON & CO.
K060493 02/24/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA. BECTON, DICKINSON & CO.
K050881 04/07/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML BECTON, DICKINSON & CO.
K090824 03/26/2009 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K090827 03/26/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K091730 06/11/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K140446 02/21/2014 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K140448 02/21/2014 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO.
K071623 06/14/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML BECTON, DICKINSON & CO.
K082913 09/30/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML BECTON, DICKINSON & CO.
K063300 11/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML BECTON, DICKINSON & CO.
K073433 12/06/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML BECTON, DICKINSON & CO.
K061327 05/12/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0. BECTON, DICKINSON & CO.
K061673 06/14/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML BECTON, DICKINSON & CO.
K062207 08/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML BECTON, DICKINSON & CO.
K062680 09/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML BECTON, DICKINSON & CO.
K062945 09/28/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML BECTON, DICKINSON & CO.


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