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Microbiology

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

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RecordFirmDate
MERIVIEW TM TRICHOMONAS (K894246)Meridian Diagnostics, Inc.1989-08-15
IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL (K885113)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
PROTEUS OX-19 IFA* (K885110)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
CAPTIA(R) RUBELLA-G (K883924)Mercia Diagnostics , Ltd.1989-08-15
IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT (K882674)Icn Immunobiologicals1989-08-15
CAPTIA(R) RUBELLA-M (K885300)Mercia Diagnostics , Ltd.1989-08-15
IFA SENSIBAC GENTAMYCIN (K892720)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF (K893519)Statlabs, Inc.1989-08-15
IFA SENSIBAC PENICILLIN (K892726)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
GONOSTAT (K883486)Technology Management & Marketing, Inc.1989-08-15
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS (K893977)Baxter Healthcare Corp1989-08-15
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY (K894002)Baxter Healthcare Corp1989-08-10
IFA SENSIBAC BACITRACIN (K892717)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC TOBRAMYCIN (K892729)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC NITROFURANTOIN (K892715)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC CINOXACIN (K892722)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
RUBELLA ELISA TEST SYSTEM (K891783)Zeus Scientific, Inc.1989-08-03
IFA SENSIBAC ERYTHROMYCIN (K892719)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC VANCOMYCIN (K892725)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC TETRACYCLINE (K892718)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) (K893905)Diagnostic Products Corp.1989-08-03
IFA SENSIBAC INIPENEM (K892727)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC CHLROAMPHENICOL (K892730)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC NEOMYCIN (K892714)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC STREPTOMYCIN (K892724)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
IFA SENSIBAC POLYMYXIN B (K892723)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
ABBOTT TESTPACK CHLAMYDIA (K893676)Abbott Laboratories1989-07-25
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893465)Immuno Concepts, Inc.1989-07-25
LYME DISEASE MICROASSAY (K890843)Diamedix Corp.1989-07-25
TOXO ELISA TEST SYSTEM (K891781)Zeus Scientific, Inc.1989-07-14
CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS (K893754)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-07-14
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893468)Immuno Concepts, Inc.1989-07-14
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 (K883871)Clinical Sciences, Inc.1989-07-14
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) (K893467)Immuno Concepts, Inc.1989-07-14
BION EBV-M (VCA) TEST SYSTEM (K893240)Bion Ent., Ltd.1989-07-14
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 (K883870)Clinical Sciences, Inc.1989-07-14
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (K893466)Immuno Concepts, Inc.1989-07-14
ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT (K891393)Orgenics, Ltd.1989-06-23
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY (K885295)Abbott Laboratories1989-06-23
IMX TOXO IGM ANTIBODY ASSAY (K890032)Abbott Laboratories1989-06-23
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM (K890610)Organon Teknika Corp.1989-06-23
IMX TOXO IGG ANTIBODY ASSAY (K890031)Abbott Laboratories1989-06-23
CELLMATICS SHLAMYDIA DETECTION SYSTEM (K893669)Difco Laboratories, Inc.1989-06-23
CLEARVIEW STREP A (K893422)Unipath , Ltd.1989-06-23
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY (K885297)Abbott Laboratories1989-06-23
MP TEST (K882596)Diatech Diagnostica , Ltd.1989-06-21
HSV-2 ELISA TEST SYSTEM (K891782)Zeus Scientific, Inc.1989-06-20
EBNA-CHECK(TM) TEST KIT (K891542)Diagnostic Technology, Inc.1989-06-20
HSV-1 ELISA TEST SYSTEM (K891162)Zeus Scientific, Inc.1989-06-20
RESUBMITTED EBV/IGM-CHECK TEST KIT (K890639)Diagnostic Technology, Inc.1989-06-20
RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 (K891990)Clinical Sciences, Inc.1989-06-15
HAEMOPHILUS TEST MEDIUM (AGAR) (K892928)Remel Co.1989-06-13
SUPER DUO (K892802)Mercia Diagnostics , Ltd.1989-06-13
LISTERIA SELECTIVE ENRICHMENT MEDIUM (K891593)Oxoid U.S.A., Inc.1989-06-09
QUIK-DOT TOXOPLASMOSIS (K890048)Ampcor, Inc.1989-06-09
SENSITITRE AUTO ID PLATE AP80 (K890057)Radiometer America, Inc.1989-06-09
RUBELLA-CUBE(TM) (K892051)Difco Laboratories, Inc.1989-06-08
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES (K891382)Ortho Diagnostic Systems, Inc.1989-06-06
CHLAMYDIAZYME BLOCKING REAGENT (K892371)Abbott Laboratories1989-06-02
GERM TUBE SOLUTION (K884720)Remel Co.1989-06-02
RAPIDEC COLI (K890626)Dms Products, Inc.1989-06-02
CMV ELISA TEST SYSTEM (K891081)Zeus Scientific, Inc.1989-06-02
MULTI-PROBE HEAD PLUS (K892369)Hamilton Co.1989-06-02
SCEPTOR DATA MANAGEMENT CENTER SOFTWARE (K891577)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-06-02
MERIFLUOR(TM) -TRICHOMONAS (K892263)Meridian Diagnostics, Inc.1989-05-24
VZV MICROASSAY (K890642)Diamedix Corp.1989-05-15
EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 (K883601)Clinical Sciences, Inc.1989-05-11
EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 (K883600)Clinical Sciences, Inc.1989-05-11
STAT TEST KIT FOR EB-VCA IGG ANTIBODY (K891086)Whittaker Bioproducts, Inc.1989-05-10
SELECTIVE RAPID UREA (K883641)Remel Co.1989-05-04
GENETIC SYSTEMS MICROPLATE WASHER (K891768)Genetic Systems Corp.1989-05-01
GENETIC SYSTEMS MICROPLATE STRIP WASHER (K891766)Genetic Systems Corp.1989-05-01
GENETIC SYSTEMS PIPETTOR/DILUTOR (K891765)Genetic Systems Corp.1989-05-01
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (K883670)Electro-Nucleonics, Inc.1989-04-28
GLOVES, PATIENT EXAMINATION (K890344)Tomarc (M) Sdn Bhd1989-04-26
FTK FECAL TRANSPORT KIT (K890134)Evergreen Scientific, Inc.1989-04-21
MARDX LYME DISEASE IGG IFA TEST SYSTEM (K890053)Mardx Diagnostics, Inc.1989-04-18
EBV EARLY ANTIGEN (R+D) (K884829)Hillcrest Biologicals1989-04-12
C. ALBICANS SCREEN (K891476)Carr-Scarborough Microbiologicals, Inc.1989-04-12
IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT (K885344)Orgenics, Ltd.1989-04-12
CMV-CUBE(TM) (K884842)Difco Laboratories, Inc.1989-04-11
MODIFIED DDI SEROCARD HERPES IGG TEST KIT (K884246)Disease Detection International, Inc.1989-04-10
MODIFIED DDI SEROCARD CMV IGG TEST KIT (K884248)Disease Detection International, Inc.1989-04-10
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM (K885293)Medical Diagnostic Technologies, Inc.1989-04-10
MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT (K884247)Disease Detection International, Inc.1989-04-10
MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT (K884249)Disease Detection International, Inc.1989-04-10
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM (K885294)Medical Diagnostic Technologies, Inc.1989-04-10
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY (K885290)Medical Diagnostic Technologies, Inc.1989-04-10
GIARDEIA(TM) (K890774)Antibodies, Inc.1989-04-04
VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT (K890840)Adi Diagnostics, Inc.1989-03-27
UBI MAGIWEL CMV IGG QUANTITATIVE (K883399)United Biotech, Inc.1989-03-27
ANAEROBIC MIC PANEL (K884831)Microtech Medical Systems, Inc.1989-03-27
CYTOMEGALOVIRUS IGG EIA KIT (K880433)De Ferris Laboratories, Inc.1989-03-27
MICROTRAK CHLAMYDIA EIA (K890196)Syva Co.1989-03-22
CARY-BLAIR TRANSPORT SYSTEM (K885245)Precision Biologicals, Inc.1989-03-21
SAF FECAL COLLECTION KIT (K885244)Precision Biologicals, Inc.1989-03-21
PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT (K890768)Genetic Systems Corp.1989-03-21
GRAM STAIN CONTROL SLIDE (K890718)Scientific Device Laboratory, Inc.1989-03-16
CRYPTOSPORIDIUM CONTROL SLIDE (K890670)Scientific Device Laboratory, Inc.1989-03-16
HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES (K890281)Cambridge Bioscience Corp.1989-03-15
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