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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