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Microbiology

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

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RecordFirmDate
PATHODX HERPES TYPING (K904167)Diagnostic Products Corp.1990-12-13
RUBEOLA IGG ELISA TEST (K904854)Gull Laboratories, Inc.1990-12-04
RUBELLA IGM ELISA TEST (K904084)Gull Laboratories, Inc.1990-12-04
ORTHO RUBELLA-M ANTIBODY ELISA TEST (K905079)Ortho Diagnostic Systems, Inc.1990-12-04
P AND T MEDIUM (K904773)Gibson Laboratories, Inc.1990-12-04
TRANSTAT-CMV(TM) (K903308)Ab Sangtec Medical1990-12-04
VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (K903882)Viral Antigens, Inc.1990-12-04
ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. (K904268)Gen-Probe, Inc.1990-11-13
EF SYNERGY QUAD (K903589)Remel Co.1990-11-13
ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST (K904463)Gen-Probe, Inc.1990-11-13
FASTIDIOUS MIC PANEL (K901598)Microtech Medical Systems, Inc.1990-11-08
VIRAL ACCU-CULSHURE TM (K903406)Medical Laboratory Automation Systems, Inc.1990-10-16
TOXO IGM ELISA TEST (K903324)Gull Laboratories, Inc.1990-10-16
CHLAMYDIA ACCU-CULSHURE TM (K903405)Medical Laboratory Automation Systems, Inc.1990-10-16
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION (K904400)Meridian Diagnostics, Inc.1990-10-16
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN (K904036)Baxter Healthcare Corp1990-10-16
EBV/EA-CHECK TM TEST KIT (K903612)Diagnostic Technology, Inc.1990-10-16
CYSTICERCOSIS SEROLOGICAL REAGENTS (K900780)Lmd Laboratories1990-10-04
ICON STREP B IMMUNOENZYMETRIC ASSAY (K902991)Hybritech, Inc.1990-10-03
QUIDEL CHLAMYDIA POSITIVE CONTROL (K903765)Quidel Corp.1990-10-02
ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST (K903556)Gen-Probe, Inc.1990-10-02
ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. (K904047)Gen-Probe, Inc.1990-10-02
CATARRHALIS TEST STRIP (K902595)Remel Co.1990-10-02
PREMIER-C. DIFFICILE TOXIN A (K903456)Meridian Diagnostics, Inc.1990-10-01
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET (K903926)Eastman Kodak Company1990-09-17
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM (K901840)Granbio, Inc.1990-09-12
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (K901156)Granbio, Inc.1990-09-12
ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST (K903201)Gen-Probe, Inc.1990-09-12
SYVA MICROTRAK EIA ACCESSORY REAGENTS (K903758)Syva Co.1990-09-12
DIRECTIGEN FLU A (K902609)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-09-10
MODIFICATION TO API UNISCEPT 20GP (K901559)Analytical Products, Inc.1990-09-10
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA (K901972)Novo Nordisk Diagnostics, Ltd.1990-09-05
MODIFICATION OF SEROCARD RUBELLA IGG TEST (K902571)Disease Detection International, Inc.1990-09-05
ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE (K897077)Gen-Probe, Inc.1990-08-23
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST (K896494)Gen-Probe, Inc.1990-08-23
REDITEST STREP A TEST KIT (K903194)Boehringer Mannheim Corp.1990-08-22
HAEMOPHILUS TEST MEDIUM (HTM) BROTH (K903425)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-08-22
FLORA-STAT URINE TRANSPORT SYSTEM (K902467)Wadley Biosciences Corp.1990-08-22
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG) (K902925)Vitek Systems, Inc.1990-08-09
SEROCARD HSV IGG ANTIBODY TEST KIT (K903070)Disease Detection International, Inc.1990-08-09
ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA. (K902213)Gen-Probe, Inc.1990-08-06
ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR. (K902908)Gen-Probe, Inc.1990-08-06
RUBELLA IGG (K902793)Pharmacia Diagnostics, Inc.1990-07-31
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K902270)Ciba Corning Diagnostics Corp.1990-07-31
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (K902661)Baxter Healthcare Corp1990-07-31
MICRORING YT (K900112)Medical Wire & Equipment Co.1990-07-31
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (K902662)Baxter Healthcare Corp1990-07-31
QUIDEL CHLAMYDIA TEST (K901660)Quidel Corp.1990-07-27
IMX CMV IGM ANTIBODY ASSAY (K900473)Abbott Laboratories1990-07-27
IMX CMV IGG ANTIBODY ASSAY (K900474)Abbott Laboratories1990-07-27
DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA (K900604)Biovir Laboratories, Inc.1990-07-26
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT (K902253)Kallestad Diag, A Div. of Erbamont, Inc.1990-07-26
PHARMACIA MUMPS IGG ELISA (K897006)Pharmacia Eni Diagnostics, Inc.1990-07-26
TOXOPLASMA GONDII IGG (K902792)Pharmacia Diagnostics, Inc.1990-07-24
PASCO MIC AND MIC/ID MODIFIED (K902739)Pasco Laboratories, Inc.1990-07-16
DMAC INDOLE REAGENT (K902640)Api Analytab Products1990-07-16
ANAEROBIC ACCU-CULSHURE(TM) (K901645)Medical Laboratory Automation Systems, Inc.1990-07-16
ACUSON V328 AND C5432 TRANSDUCERS (K897151)Acuson Corp.1990-07-03
RUBELLA IGG ELISA TEST (K901635)Gull Laboratories, Inc.1990-06-28
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (K901493)Whittaker Bioproducts, Inc.1990-06-27
MICROMATE 196 MODEL A961960 (K901808)Packard Instrument Co., Inc.1990-06-20
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. (K901397)Gen-Probe, Inc.1990-06-20
DRYSLIDE, BETA-LACTAMASE (K901784)Difco Laboratories, Inc.1990-06-20
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET (K901934)Eastman Kodak Company1990-06-20
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (K902259)Orthomet, Inc.1990-06-18
ZEFAZONE SUSCEPTIBILITY TEST DISKS (K902082)Difco Laboratories, Inc.1990-06-15
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT (K900546)Baxter Healthcare Corp1990-06-15
PATHODX PYR KIT (K902037)Diagnostic Products Corp.1990-06-01
PATHO DX STREP D (K902038)Diagnostic Products Corp.1990-05-21
CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST (K901243)Cel Labs Pty, Ltd.1990-05-21
VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT (K900688)Clinical Sciences, Inc.1990-05-15
CELLOGNOST SYPHILIS H (K896410)Behring Diagnostics, Inc.1990-05-15
TROBICIN SUSCEPTIBILITY POWDER (K902004)The Upjohn Co.1990-05-15
VISUWELL(R) CHLAMYDIA (K900973)Adi Diagnostics, Inc.1990-05-15
ASO-CUBE(TM) (K901371)Difco Laboratories, Inc.1990-05-15
HERPTRAN CONCENTRATE (K900713)E.I. Dupont DE Nemours & Co., Inc.1990-05-11
VITEK ANAEROBE IDENTIFICATION CARD (K900996)Vitek Systems, Inc.1990-05-11
TESTPACK PLUS STREP A (K901274)Abbott Laboratories1990-05-11
CHLAMYDIAZYME DIAGNOSTIC KIT (K900543)Abbott Laboratories1990-05-03
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K897078)Gen-Probe, Inc.1990-05-02
LYME IGM MICROASSAY (K900572)Diamedix Corp.1990-05-02
LYME IGM ELISA TEST SYSTEM (K900196)Zeus Scientific, Inc.1990-05-02
CMV IGG ELISA TEST (K900796)Gull Laboratories, Inc.1990-05-02
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO. (K900818)Vitek Systems, Inc.1990-04-30
RESUBMITTED MODIFIED RUBALEX (K901637)Orion Corp.1990-04-26
CMV-IGM IFA TEST SYSTEM (K900743)Zeus Scientific, Inc.1990-04-26
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST (K896492)Gen-Probe, Inc.1990-04-16
INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (K900974)Stellar Bio Systems, Inc.1990-04-16
TOXO IGG ELISA TEST (K900354)Gull Laboratories, Inc.1990-04-16
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST (K900870)Diagnostic Products Corp.1990-04-16
DMAC INDOLE REAGENT (K901390)Analytical Products, Inc.1990-04-16
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST (K896493)Gen-Probe, Inc.1990-04-11
VISUWELL(R) REAGIN TEST (MODIFICATION) (K900338)Adi Diagnostics, Inc.1990-04-10
BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE (K901054)Bion Ent., Ltd.1990-04-05
SNAP MYCOBACTERIA AVIUM COMPLEX (K900202)Syngene, Inc.1990-04-03
SNAP M. TUBERCULOSIS COMPLEX (K900292)Syngene, Inc.1990-04-03
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING (K900821)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-03-15
PLATELIA TOXO IGM KIT (K894948)Kallestad Diag, A Div. of Erbamont, Inc.1990-03-15
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG (K895468)Orgenics, Ltd.1990-03-13
RAPID NF SYSTEM (K900517)Innovative Diagnostic Systems, Inc.1990-03-13
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