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289 FDA 510(k) clearances · Product code

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RecordFirmDate
VITEK 2 GRAM NEGATIVE ERTAPENEM (K041982)bioMerieux, Inc.2004-09-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML (K041572)Becton, Dickinson and Co.2004-08-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE (K041384)Becton, Dickinson & CO2004-08-03
VITEK 2 ESBL TEST (K040845)bioMerieux, Inc.2004-06-08
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST (K033458)Becton, Dickinson & CO2004-05-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML (K040716)Becton, Dickinson & CO2004-05-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML (K033907)Becton, Dickinson & CO2004-04-09
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE (K033362)Becton, Dickinson & CO2004-04-09
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML) (K031601)Dade Behring, Inc.2004-04-02
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K040099)Becton, Dickinson & CO2004-03-19
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE (K040106)Becton, Dickinson & CO2004-03-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML (K032675)Becton, Dickinson & CO2004-03-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE (K040006)Becton, Dickinson & CO2004-02-27
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE (K033889)Becton, Dickinson & CO2004-02-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML (K033784)Becton, Dickinson & CO2004-02-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K033560)Becton, Dickinson & CO2004-01-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE (K033557)Becton, Dickinson & CO2004-01-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K033558)Becton, Dickinson & CO2003-12-19
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) (K033482)Dade Behring, Inc.2003-11-26
MYCOPLASMA IGG (K033064)Trinity Biotech USA2003-11-26
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN (K032861)bioMerieux, Inc.2003-11-12
VITEK 2 GRAM NEGATIVE GATIFLOXACIN (K032788)bioMerieux, Inc.2003-11-04
VITEK 2 GRAM POSITIVE LINEZOLID (K032766)bioMerieux, Inc.2003-10-31
VITEK GRAM NEGATIVE GATIFLOXACIN (K032711)bioMerieux, Inc.2003-10-31
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN (K032738)bioMerieux, Inc.2003-10-31
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML (K032655)Becton, Dickinson & CO2003-10-06
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K032275)Becton, Dickinson & CO2003-09-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML (K032299)Becton, Dickinson & CO2003-09-22
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE (K032567)Becton, Dickinson & CO2003-09-17
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML (K032153)Bd Diagnostic Systems2003-09-11
VITEK 2 GRAM POSITIVE MOXIFLOXACIN (K032399)bioMerieux, Inc.2003-09-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML (K031984)Becton, Dickinson & CO2003-08-27
VITEK 2 GRAM POSITIVE GATIFLOXACIN (K032314)bioMerieux, Inc.2003-08-22
BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS (K032131)Becton, Dickinson & CO2003-08-18
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE (K031865)bioMerieux, Inc.2003-08-13
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML (K031943)Becton, Dickinson & CO2003-08-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) (K031602)Dade Behring, Inc.2003-07-31
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML (K031699)Becton, Dickinson & CO2003-07-30
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML (K031912)Becton, Dickinson & CO2003-07-21
BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM (K031679)Becton, Dickinson & CO2003-07-16
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE (K031589)Becton, Dickinson & CO2003-07-11
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE (K031410)bioMerieux, Inc.2003-07-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML (K031530)Becton, Dickinson & CO2003-07-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML (K031429)Bd Diagnostic Systems2003-06-06
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE (K031306)Becton, Dickinson & CO2003-06-02
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML (K030986)Becton, Dickinson & CO2003-05-16
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE (K030677)Becton, Dickinson & CO2003-04-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML (K030579)Becton, Dickinson & CO2003-03-21
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML (K030091)Bd Diagnostic Systems2003-02-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML (K024153)Becton, Dickinson & CO2003-02-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML (K024152)Becton, Dickinson & CO2003-01-31
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K023568)Becton, Dickinson & CO2003-01-24
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN (K023895)Becton, Dickinson & CO2003-01-08
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) (K023634)Becton, Dickinson & CO2002-12-24
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML (K023527)Becton, Dickinson & CO2002-12-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K023858)Becton, Dickinson & CO2002-12-20
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) (K023361)Dade Behring, Inc.2002-12-16
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) (K023541)Dade Behring, Inc.2002-12-13
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML (K023444)Becton, Dickinson & CO2002-11-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K023301)Becton, Dickinson & CO2002-11-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML (K023273)Becton, Dickinson & CO2002-10-31
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID (K022045)bioMerieux, Inc.2002-08-15
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K022172)Becton, Dickinson & CO2002-08-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML (K021954)Becton, Dickinson & CO2002-08-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML (K022129)Becton, Dickinson & CO2002-07-25
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) (K020413)Dade Behring, Inc.2002-07-17
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) (K020410)Dade Behring, Inc.2002-06-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K020321)Becton, Dickinson & CO2002-05-23
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) (K020398)Dade Behring, Inc.2002-05-16
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) (K020397)Dade Behring, Inc.2002-04-22
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) (K020506)Dade Microscan, Inc.2002-04-17
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML) (K020319)Dade Behring, Inc.2002-04-17
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K020323)Becton, Dickinson & CO2002-04-04
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN (K020871)bioMerieux, Inc.2002-03-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K020322)Becton, Dickinson & CO2002-03-27
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN (K020870)bioMerieux, Inc.2002-03-25
MICROSCAN SYNERGIES PLUS (K020142)Dade Behring, Inc.2002-03-14
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) (K020248)Dade Behring, Inc.2002-03-14
MICROSCAN SYNERGIES PLUS (K020511)Dade Microscan, Inc.2002-03-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) (K020328)Dade Behring, Inc.2002-02-19
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) (K020185)Dade Behring, Inc.2002-02-06
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) (K020249)Dade Behring, Inc.2002-02-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) (K020209)Dade Behring, Inc.2002-02-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) (K020246)Dade Behring, Inc.2002-02-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) (K020182)Dade Behring, Inc.2002-02-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) (K020173)Dade Behring, Inc.2002-02-06
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) (K020168)Dade Behring, Inc.2002-02-06
SCEPTOR DATA MANAGEMENT CENTER SOFTWARE (K891577)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-06-02
REPLIANALYZER (K861958)Mct Medical, Inc.1986-08-01
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