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Microbiology

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

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RecordFirmDate
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (K895915)Meridian Diagnostics, Inc.1990-03-12
MODIFIED CAPTIA(R) SYPHILIS-M (K900654)Mercia Diagnostics , Ltd.1990-03-08
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT (K900402)Eastman Kodak Company1990-03-08
ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE (K897079)Gen-Probe, Inc.1990-03-08
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN (K896278)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-03-07
CAPTIA(R) CMV-M (K896295)Mercia Diagnostics , Ltd.1990-03-06
CAPTIA(R) CMV-G (K896194)Mercia Diagnostics , Ltd.1990-03-06
MODIFIED CAPTIA(R) TOXO-M (K900655)Mercia Diagnostics , Ltd.1990-03-06
SPECIMEN CONTAINER (K896794)Westmark, Sterile Packing Systems, Inc. (Sps)1990-03-01
CMV IGM ELISA TEST SYSTEM (K896355)Zeus Scientific, Inc.1990-02-27
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY (K896097)Vitek Systems, Inc.1990-02-26
QUIDEL GROUP B STREP TEST (K896265)Quidel Corp.1990-02-16
ZEFAZONE SUSCEPTIBILITY POWDER (K900455)The Upjohn Co.1990-02-09
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE (K896566)Medical Specialties, Inc.1990-02-09
CEFIXIME 5 MCG SUSCEPTIBILITY DISK (K900344)Organon Teknika Corp.1990-02-05
SUPPLEMENT TO ANAEROBIC MIC PANEL (K896332)Microtech Medical Systems, Inc.1990-02-05
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY (K896635)Baxter Healthcare Corp1990-02-02
ROMCHECK SPECIMEN COLLECTION KIT (K900225)Adeza Biomedical1990-02-02
ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST (K896859)Gen-Probe, Inc.1990-02-01
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 (K895839)Diagnostic Products Corp.1990-02-01
MODIFIED ELISA FOR CHLAMYDIA (K896032)Fairleigh Dickinson Laboratories, Inc.1990-01-29
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K896965)Alamar Biosciences Laboratory, Inc.1990-01-29
PASCO MIC/ID GRAM-POSITIVE PANEL (K895215)Difco Laboratories, Inc.1990-01-29
INPOUCH-TV POUCH (K896296)Biomed Diagnostics, Inc.1990-01-29
CLEARVIEW CHLAMYDIA (K895280)Unipath , Ltd.1990-01-29
VENTRESIGN STREP A TEST (K897083)Ventrex Laboratories, Inc.1990-01-22
EBV VCA ANTIBODY (IGM) (K896594)Hillcrest Biologicals1990-01-16
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (K893579)Whittaker Bioproducts, Inc.1990-01-16
WELLCOLEX COLOUR SHIGELLA TEST ZC51 (K895461)Wellcome Diagnostics1990-01-11
CEFMATZOLE 30 MCG SENSI DISC (K895679)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-01-02
AUTOSCEPTOR (K896447)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-01-02
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES) (K895505)Eastman Kodak Company1990-01-02
ORTHO* RUBELLA-G ANTIBODY ELISA TEST (K896479)Ortho Diagnostic Systems, Inc.1989-12-29
PLATELIA RUBELLA IGG KIT (K894946)Kallestad Diag, A Div. of Erbamont, Inc.1989-12-21
DIATECH IGM-MP TEST (K895276)Diatech Diagnostica , Ltd.1989-12-18
DIFCO OXIDASE DRYSLIDE (K896398)Difco Laboratories, Inc.1989-12-18
DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST (K893200)Gull Laboratories, Inc.1989-12-18
EBV-EA IFA KIT (K895652)Organon Teknika Treyburn1989-12-18
DETECTADOT TM SYSTEM 2000 CMV IGM TEST (K893230)Gull Laboratories, Inc.1989-12-18
LYME IGG ELISA TEST SYSTEM (K895292)Zeus Scientific, Inc.1989-12-13
CARDS O.S.(TM) STREP A (K896221)Pacific Biotech, Inc.1989-12-13
HAEMOPHILUS TEST MEDIUM (HTM)AGAR (K894216)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-13
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) (K895708)Immuno Concepts, Inc.1989-12-11
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) (K895707)Immuno Concepts, Inc.1989-12-08
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST (K895362)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-01
IFA SENSIBAC CEFACLOR (K892721)Investigacion Farmaceutica S.A. DE C.V.1989-11-30
IMMUNOCARD STREP A TEST (K896109)Disease Detection International, Inc.1989-11-29
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION (K895103)Gen-Probe, Inc.1989-11-29
MODIFIED RUBAGEN (K896433)Biokit USA, Inc.1989-11-29
IDEIA HERPES SIMPLEX VIRUS TEST (K871877)Boots-Celltech Diagnostics, Inc.1989-11-17
OLYMPUS PK(TM) TP (K893124)Fujirebio Diagnostics,Inc.1989-11-17
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (K894712)Gen-Probe, Inc.1989-11-14
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. (K895583)Gen-Probe, Inc.1989-11-14
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. (K894711)Gen-Probe, Inc.1989-11-14
API UNISCEPT KB (K895796)Analytical Products, Inc.1989-11-13
RAPIDEC STAPH (K891004)Dms Products, Inc.1989-11-09
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K894514)Alamar Biosciences Laboratory, Inc.1989-11-06
OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (K894617)Schiff & Co.1989-10-31
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K895122)Ciba Corning Diagnostics Corp.1989-10-30
IMMUNODOT LYME TEST (K894410)General Biometrics, Inc.1989-10-30
FDL, INC.'S TRANSPORT SYSTEM (K895187)Fairleigh Dickinson Laboratories, Inc.1989-10-24
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) (K894486)Biokit USA, Inc.1989-10-24
ANTIMICROBIAL SUSCEPTIBILITY DISK (K895392)Organon Teknika Corp.1989-10-24
VARICELLA ZOSTER VIRUS (K894622)Bion Ent., Ltd.1989-10-24
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (K894645)Dynatech Laboratories, Inc.1989-10-17
EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (K894626)Bion Ent., Ltd.1989-10-16
RESPIRATORY SYNCYTIAL VIRUS (K894623)Bion Ent., Ltd.1989-10-16
TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN (K894261)Microbix Biosystems, Inc.1989-10-16
RUBELLA ANTIGEN AND CONTROL ANTIGEN (K894262)Microbix Biosystems, Inc.1989-10-16
IMMUNODOT RUBELLA TEST (K894546)General Biometrics, Inc.1989-10-16
IMMUNO/ASO (K894780)Immunostics Co., Inc.1989-10-16
DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST (K893753)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-16
MUMPS VIRUS (K894624)Bion Ent., Ltd.1989-10-16
FIAX EB VCA-M TEST KIT (K894932)Whittaker Bioproducts, Inc.1989-10-16
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID (K894189)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-10
ROSCO PYRR (K894221)Pro-Lab, Inc.1989-09-28
RAPIDEC UR (K894805)Dms Products, Inc.1989-09-26
IFA SENSIBAC NORFLOXACIN (K892728)Investigacion Farmaceutica S.A. DE C.V.1989-09-21
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM (K894609)Mardx, Inc.1989-09-19
GEN-PROBE PACE SYSTEM URINE SCREEN (K892216)Gen-Probe, Inc.1989-09-15
DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST (K892202)Gull Laboratories, Inc.1989-09-13
CEFIXIME 5 MCG SENSITIVITY DISKS (K894829)Difco Laboratories, Inc.1989-09-08
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE (K894845)Meridian Diagnostics, Inc.1989-09-08
HAEMOPHILUS TEST MEDIUM (BROTH) (K894848)Regional Media Laboratories1989-09-06
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS (K894146)Baxter Healthcare Corp1989-09-05
BION EBV-G (VCA) TEST SYSTEM (K891785)Bion Ent., Ltd.1989-08-31
SENSITITRE INDOLE REAGENT (K894776)Radiometer America, Inc.1989-08-31
EB VCA STAT M TEST KIT (K894235)Whittaker Bioproducts, Inc.1989-08-30
BIOTROL RUB-E.I.A. TEST G (K894544)Biotrol, USA, Inc.1989-08-30
MARDX LYME DISEASE EIA (IGM) TEST SYSTEM (K894293)Mardx Diagnostics, Inc.1989-08-21
SPECTINOMYCIN 100 MCG SENSI-DISC (K891772)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-08-21
RUBAGEN (K893755)Biokit USA, Inc.1989-08-21
MARDX LYME DISEASE EIA (IGG) TEST SYSTEM (K894224)Mardx Diagnostics, Inc.1989-08-21
IFA SENSIBAC KANAMYCIN (K892733)Investigacion Farmaceutica S.A. DE C.V.1989-08-17
IFA SENSIBAC CEPHALOTIN (K892735)Investigacion Farmaceutica S.A. DE C.V.1989-08-17
IFA SENSIBAC NALIDIXIC ACID (K892713)Investigacion Farmaceutica S.A. DE C.V.1989-08-17
CHLAMYDIA (LGV-1) (K894625)Bion Ent., Ltd.1989-08-15
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM (K892206)Mardx Diagnostics, Inc.1989-08-15
LEECO VIS-DISK STREP-A (EIA) (K894122)Leeco Diagnostics, Inc.1989-08-15
BRUCELLA IFA* (K885112)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
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