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Microbiology

6,936 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974503)Roche Molecular Systems, Inc.1999-12-01
CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC (K993577)Becton Dickinson Microbiology Systems1999-12-01
HYBRID CAPTURE II GC-ID (K981485)Digene Corp.1999-11-29
SIRSCAN (K991473)Intelligence Artificielle Applications1999-11-23
ETEST FOR QUINUPRISTIN/DALFOPRISTIN (K992993)Ab Biodisk1999-11-16
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM (K993161)Copan Diagnostics, Inc.1999-11-09
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (K991880)Light Diagnostics1999-11-09
PASCO MIC AND MIC/ID PANELS, CEFDINIR (K992853)Pasco Laboratories, Inc.1999-11-04
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY (K984631)Becton Dickinson Microbiology Systems1999-11-04
SYNERCID, 15 UG, BBL SENSI-DISC (K993186)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-11-03
PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS (K992726)Pasco Laboratories, Inc.1999-11-03
CDTOX A OIA (K991829)Biostar, Inc.1999-11-02
SERAQUEST EB NA IGG (K991975)Quest Intl., Inc.1999-11-02
PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN (K992717)Pasco Laboratories, Inc.1999-11-02
SERAQUEST EB VCA IGG (K990410)Quest Intl., Inc.1999-10-28
HYBRID CAPTURE II CT-ID TEST (K990023)Digene Corp.1999-10-25
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (K990141)Light Diagnostics1999-10-19
PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN (K992647)Pasco Laboratories, Inc.1999-10-19
PASCO MIC AND MIC/ID PANELS, PENICILLIN (K992646)Pasco Laboratories, Inc.1999-10-19
PASCO MIC AND MIC/ID PANELS, CEFOTAXIME (K992568)Pasco Laboratories, Inc.1999-10-14
PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL (K992593)Pasco Laboratories, Inc.1999-10-14
PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE (K992562)Pasco Laboratories, Inc.1999-10-13
PASCO MIC AND MIC/ID PANELS, MEROPENEM (K992546)Pasco Laboratories, Inc.1999-10-12
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN (K992507)Pasco Laboratories, Inc.1999-10-08
SERAQUEST EB VAC IGM (K990977)Quest Intl., Inc.1999-10-06
MODIFICATION OF PASCO MIC AND MIC/ID PANELS (K992420)Pasco Laboratories, Inc.1999-09-27
BACT/ALERT FN (K992432)Organon Teknika Corp.1999-09-24
QUICKVUE INFLUENZA A/B TEST (K991633)Quidel Corp.1999-09-24
EZ-HBT HELICOBACTER BLOOD TEST (K990931)Metabolic Solutions, Inc.1999-09-24
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 (K991062)Immunetics, Inc.1999-09-21
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 (K991063)Immunetics, Inc.1999-09-21
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN (K992296)Pasco Laboratories, Inc.1999-09-21
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI (K992124)Avanti Polar Lipids, Inc.1999-09-20
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN) (K992143)Pasco Laboratories, Inc.1999-09-16
NUCLISENS CMV PP67 (K983762)Organon Teknika Corp.1999-09-15
MUMPS IGG ELISA TEST SYSTEM (K991274)Columbia Bioscience, Inc.1999-09-03
PASCO MIC AND MIC/ID PANELS (CEFEPIME) (K992108)Pasco Laboratories, Inc.1999-09-03
PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN (K992297)Pasco Laboratories, Inc.1999-09-03
PASCO MIC AND MIC/ID PANELS (OFLOXACIN) (K992077)Pasco Laboratories, Inc.1999-09-03
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K992166)Zeus Scientific, Inc.1999-09-03
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM (K991185)Zeus Scientific, Inc.1999-09-03
BACT/ALERT PF (K992401)Organon Teknika Corp.1999-09-03
BACTALERT FA (K992400)Organon Teknika Corp.1999-09-03
IS H. PYLORI IGG ELISA TEST SYSTEM (K990462)Columbia Bioscience, Inc.1999-09-03
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM (K991180)Zeus Scientific, Inc.1999-09-03
PASCO MIC AND MIC/ID PANELS (CEFUROXIME) (K992076)Pasco Laboratories, Inc.1999-08-30
PASCO MIC AND MIC/ID PANELS (K992059)Pasco Laboratories, Inc.1999-08-30
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI (K991726)Binax, Inc.1999-08-27
PASCO MIC AND MIC/ID PANELS (K991925)Pasco Laboratories, Inc.1999-08-26
SAS ADENO TEST (K990630)Sa Scientific, Inc.1999-08-19
POCKIT HSV 2 RAPID TEST (K983886)Diagnology , Ltd.1999-08-19
STREP B OIA (K991828)Biostar, Inc.1999-08-19
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI (K991820)Zeus Scientific, Inc.1999-08-12
GONOSTAT GONOCOCCAL DETECTION KIT (K991268)Sierra Diagnostics1999-08-11
LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 (K992252)Chemicon Intl., Inc.1999-08-10
IMMUNOCARD STAT! E. COLI O157:H7 (K990263)Meridian Diagnostics, Inc.1999-08-09
SAS ROTA TEST (K990842)Sa Scientific, Inc.1999-08-09
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973707)Roche Molecular Systems, Inc.1999-08-04
QUICKVUE ONE-STEP H. PYLORI II TEST (K991747)Quidel Corp.1999-08-04
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM (K984180)Zeus Scientific, Inc.1999-07-20
ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (K972772)Trek Diagnostic Systems, Inc.1999-07-13
CMV BRITE TURBO KIT (K991650)Biotest Diagnostics Corp.1999-07-12
ETI-EA-G ASSAY (K992191)DiaSorin, Inc.1999-07-12
VELOGENE RAPID MRSA IDENTIFICATION ASSAY (K990640)Id Biomedical Corp.1999-07-09
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (K984346)Meridian Diagnostics, Inc.1999-06-25
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (K984343)Meridian Diagnostics, Inc.1999-06-25
PRONTO DRY (K991248)Medical Instruments Corporation Mic AG1999-06-22
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K983922)Dade Microscan, Inc.1999-06-17
BIOTEST ANTI-EBV RECOMBINANT (K983839)Biotest Diagnostics Corp.1999-06-09
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG (K983841)Biotest Diagnostics Corp.1999-06-09
BIOTEST ANTI-EBV RECOMBINANT, EA IGM (K983842)Biotest Diagnostics Corp.1999-06-09
COPALIS MULTIPLEX EBV ANTIBODY ASSAY (K991660)DiaSorin, Inc.1999-06-04
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974342)Roche Molecular Systems, Inc.1999-05-28
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO (K983805)Zeus Scientific, Inc.1999-05-26
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH (K984120)Zeus Scientific, Inc.1999-05-26
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984135)Zeus Scientific, Inc.1999-05-26
COPALIS EBV-M ANTIBODY ASSAY (K991459)DiaSorin, Inc.1999-05-14
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K983408)Dade Microscan, Inc.1999-05-10
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K983711)Dade Microscan, Inc.1999-04-27
ETEST FOR CEFUROXIME (K990722)Ab Biodisk1999-04-22
QUANTA LITE LYME IGG ELISA (K984222)Inova Diagnostics, Inc.1999-04-15
QUANTA LITE LYME IGM ELISA (K984234)Inova Diagnostics, Inc.1999-04-15
TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K984513)Oxoid , Ltd.1999-04-02
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW (K990664)Intracel Corp.1999-03-31
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) (K990685)Ab Biodisk1999-03-26
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM (K984138)Zeus Scientific, Inc.1999-03-23
ETEST MINOCYCLINE (K990297)Ab Biodisk1999-03-22
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (K983336)Diagnostic Products Corp.1999-03-18
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (K983656)Zeus Scientific, Inc.1999-03-18
ENTERO-TEST HP, MODEL #102-01 (K983119)Hdc Corp.1999-03-15
GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K984608)Oxoid , Ltd.1999-03-09
SYSTEM U3 FOR CEFUROXIME (K984491)Ab Biodisk1999-03-09
SYSTEM U3 FOR CEPHALOTHIN (K984581)Ab Biodisk1999-03-09
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT (K980351)Boston Biomedica, Inc.1999-03-05
EBV-VCA IGG ELISA TEST SYSTEM (K981812)Diamedix Corp.1999-03-04
VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES (K984596)Zymetx, Inc.1999-03-04
HSV 1+2 IGG ELISA TEST (K983541)Gull Laboratories, Inc.1999-02-26
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S (K984544)Enteric Products, Inc.1999-02-18
SYSTEM U3 (K983890)Ab Biodisk1999-02-18
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K984489)Accumed Intl., Inc.1999-02-16
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