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289 FDA 510(k) clearances · Product code

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RecordFirmDate
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML (K082852)Becton, Dickinson & CO2009-01-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML (K082913)Becton, Dickinson & CO2008-12-05
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST (K082538)Becton, Dickinson & CO2008-11-20
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE (K080201)bioMerieux, Inc.2008-04-30
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS (K073589)Becton, Dickinson & CO2008-03-05
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM (K080107)bioMerieux, Inc.2008-02-28
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE (K073406)bioMerieux, Inc.2008-01-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML (K073433)Becton, Dickinson & CO2008-01-14
VITEK 2 GRAM NEGATIVE PIPERACILLIN (K073083)bioMerieux, Inc.2007-12-10
VITEK 2 GRAM POSITIVE TIGECYCLINE (K072695)bioMerieux, Inc.2007-11-16
VITEK 2 GRAM POSITIVE VANCOMYCIN (K072668)bioMerieux, Inc.2007-10-15
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML (K070809)Becton, Dickinson & CO2007-09-24
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN (K072038)bioMerieux, Inc.2007-09-12
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN (K071317)Dade Behring, Inc.2007-08-20
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML (K071623)Becton, Dickinson & CO2007-08-20
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM (K070346)Dade Behring, Inc.2007-07-18
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE (K071268)Dade Behring, Inc.2007-06-26
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K071076)Dade Behring, Inc.2007-05-21
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN (K070860)Dade Behring, Inc.2007-05-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY (K063486)Becton, Dickinson & CO2007-03-07
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML (K063824)Becton, Dickinson & CO2007-02-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML (K063811)Becton, Dickinson & CO2007-02-09
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) (K063564)Dade Behring, Inc.2007-02-08
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML (K063300)Becton, Dickinson & CO2007-01-29
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE (K063597)bioMerieux, Inc.2007-01-19
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE (K063623)bioMerieux, Inc.2007-01-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML (K063573)Becton, Dickinson & CO2007-01-11
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K063492)bioMerieux, Inc.2006-12-21
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE (K063365)Dade Behring, Inc.2006-12-08
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML (K063301)Becton, Dickinson & CO2006-12-08
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE (K063366)Dade Behring, Inc.2006-12-08
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML (K062945)Becton, Dickinson & CO2006-11-21
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML (K062938)Dade Behring, Inc.2006-11-20
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML (K062944)Becton, Dickinson & CO2006-11-15
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML (K062687)Becton, Dickinson & CO2006-10-24
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID (K062705)Dade Behring, Inc.2006-10-20
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML (K062680)Becton, Dickinson & CO2006-10-05
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML (K062207)Becton, Dickinson & CO2006-09-13
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML (K062206)Becton, Dickinson & CO2006-09-08
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML (K061869)Becton, Dickinson & CO2006-08-18
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML (K061867)Becton, Dickinson & CO2006-08-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML (K061673)Becton, Dickinson & CO2006-07-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0. (K061327)Becton, Dickinson & CO2006-07-03
VITEK 2 GRAM POSITIVE VRSA SCREEN (K061347)bioMerieux, Inc.2006-06-20
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML (K061355)Becton, Dickinson & CO2006-06-07
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE (K060324)Becton, Dickinson & CO2006-05-25
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML (K060558)Becton, Dickinson & CO2006-05-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) (K060447)Becton, Dickinson & CO2006-04-26
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML (K060257)Becton, Dickinson & CO2006-04-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML (K060217)Becton, Dickinson & CO2006-04-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML (K060444)Becton, Dickinson & CO2006-04-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA. (K060493)Becton, Dickinson & CO2006-03-29
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML) (K060312)Dade Behring, Inc.2006-03-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML (K060218)Becton, Dickinson & CO2006-03-17
BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML (K060214)Becton, Dickinson & CO2006-03-09
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) (K053504)Dade Behring, Inc.2006-02-24
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN (K060088)Dade Behring, Inc.2006-02-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML (K053241)Becton, Dickinson & CO2005-12-22
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN (K053097)bioMerieux, Inc.2005-12-14
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K053186)bioMerieux, Inc.2005-12-01
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN (K052656)bioMerieux, Inc.2005-11-07
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K052346)Dade Behring, Inc.2005-10-26
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML (K052270)Becton, Dickinson & CO2005-10-05
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN (K052269)Becton, Dickinson & CO2005-10-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML (K052250)Becton, Dickinson & CO2005-09-30
VITEK 2 GRAM NEGATIVE TIGECYCLINE (K052311)bioMerieux, Inc.2005-09-29
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE (K051849)bioMerieux, Inc.2005-08-16
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML (K051689)Becton, Dickinson & CO2005-08-05
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN (K051478)Dade Behring, Inc.2005-07-27
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K051350)Dade Behring, Inc.2005-07-25
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML (K051692)Becton, Dickinson & CO2005-07-14
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN (K051311)Dade Behring, Inc.2005-07-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML (K051272)Becton, Dickinson & CO2005-07-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML (K051266)Becton, Dickinson & CO2005-07-05
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML (K051204)Becton, Dickinson & CO2005-06-24
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML (K051183)Becton, Dickinson & CO2005-06-21
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML (K051109)Becton, Dickinson & CO2005-06-15
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML (K051138)Becton, Dickinson & CO2005-06-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML (K050946)Becton, Dickinson & CO2005-05-27
BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) (K050982)Becton, Dickinson & CO2005-05-24
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE (K050976)bioMerieux, Inc.2005-05-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML (K050865)Becton, Dickinson & CO2005-05-20
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML (K050881)Becton, Dickinson & CO2005-05-12
BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML (K050780)Becton, Dickinson & CO2005-05-12
VITEK 2 GRAM POSITIVE MEROPENEM (K050816)bioMerieux, Inc.2005-05-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML (K050747)Becton, Dickinson & CO2005-04-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML (K050745)Becton, Dickinson & CO2005-04-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML (K050555)Becton, Dickinson & CO2005-04-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML (K050400)Becton, Dickinson & CO2005-03-22
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML (K043458)Becton, Dickinson & CO2005-03-15
VITEK 2 GRAM POSITIVE DAPTOMYCIN (K050075)bioMerieux, Inc.2005-02-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML (K050089)Becton, Dickinson & CO2005-02-28
VITEK 2 GRAM POSITIVE ERTAPENEM (K050076)bioMerieux, Inc.2005-02-18
VITEK 2 COMPACT (K050002)bioMerieux, Inc.2005-02-17
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML (K043389)Becton, Dickinson & CO2005-01-21
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM (K043230)bioMerieux, Inc.2004-12-30
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN (K043237)bioMerieux, Inc.2004-12-23
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM (K042963)bioMerieux, Inc.2004-12-13
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN (K042946)bioMerieux, Inc.2004-12-07
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML (K042932)Becton, Dickinson & CO2004-12-02
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