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Microbiology

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

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RecordFirmDate
BARTELS RUBELLA IGM EIA (K922581)Baxter Diagnostics, Inc.1992-09-17
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA (K921628)Incstar Corp.1992-09-14
OPUS(R) TOXO-G TEST SYSTEM (K921523)Pb Diagnostics, Inc.1992-09-14
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED (K923445)Hycor Biomedical, Inc.1992-09-11
ROCHE ENTEROTUBE II (K922588)Roche Diagnostic Systems, Inc.1992-09-11
PROSPECT GIARDIA CONTROLS (K922675)Alexon, Inc.1992-09-11
BARTELS TOXOPLASMA IGG EIA (K922585)Baxter Diagnostics, Inc.1992-09-02
BARTELS EPSTEIN-BARR VIRUS IGM EIA (K922331)Baxter Diagnostics, Inc.1992-09-02
BARTELS LYME DISEASE IGM EIA (K922578)Baxter Diagnostics, Inc.1992-09-02
BARTELS EPSTEIN-BARR VIRUS IGG EIA (K922332)Baxter Diagnostics, Inc.1992-09-02
BARTELS TOXOPLASMA IGM EIA (K922579)Baxter Diagnostics, Inc.1992-09-02
BARTELS RUBEOLA IGM EIA (K922335)Baxter Diagnostics, Inc.1992-09-02
BARTELS RUBEOLA IGG EIA (K922330)Baxter Diagnostics, Inc.1992-09-02
RUBELLA IGM (K921573)Clark Laboratories, Inc.1992-08-27
BIOSTARS STREP A OIA -- MODIFICATION (K922765)Biosearch Medical Products, Inc.1992-08-20
MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM (K920212)Shared Systems, Inc.1992-08-20
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K922780)Alamar Biosciences Laboratory, Inc.1992-08-20
ANTIMICROBIAL SUSCETIBILITY TEST PANEL (K922003)Alamar Biosciences Laboratory, Inc.1992-08-19
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT (K921616)Incstar Corp.1992-08-11
ORTHO CHLAMYDIA ANTIGEN ELISA TEST (K921321)Ortho Diagnostic Systems, Inc.1992-08-11
PERMIER HISTOPLASMA (K915700)Meridian Diagnostics, Inc.1992-07-30
TURKEL THORACENTESIS NEEDLE (K921461)Symbiosis Corp.1992-07-30
AFFIRM VP SAMPLE COLLECTION SET (K920536)Microprobe Corp.1992-07-30
LEGIONELLA STAT IGG/IGM TEST KIT (K911356)Whittaker Bioproducts, Inc.1992-07-30
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (K921421)Pro-Lab, Inc.1992-07-28
LORACARBEF 30MCG DISK (K922791)Difco Laboratories, Inc.1992-07-28
ENOXACIN (K922794)Difco Laboratories, Inc.1992-07-28
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K922168)Alamar Biosciences Laboratory, Inc.1992-07-28
CEFZIL (K922793)Difco Laboratories, Inc.1992-07-28
PHARMACIA CMV IGM ELISA (K921011)Pharmacia Diagnostics, Inc.1992-07-27
HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS (K920222)Akers Research Corp.1992-07-27
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K921435)Gen-Probe, Inc.1992-07-23
ABBOTT STREP A CONTROLS (K922490)Abbott Laboratories1992-07-22
TESTPACK PLUS STREP A (K922345)Abbott Laboratories1992-07-16
AMRAD HEL-PTEST (K920827)Amrad1992-07-14
ESP BLOOD CULTURE SYSTEM (K921637)Difco Laboratories, Inc.1992-07-14
PREMIER COCCIDIOIDES (K915493)Meridian Diagnostics, Inc.1992-07-10
TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO (K920702)Pharmacia Diagnostics, Inc.1992-07-08
BACTEC 9120 SYSTEM (K922475)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-07-01
SENSITITRE ARIS MODULE (K911419)Sensititre , Ltd.1992-07-01
COXSACKIE VIRUS B1-B6 CF ANTIGENS (K921618)Virion (U.S.), Inc.1992-06-29
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM (K921556)Medical Diagnostic Technologies, Inc.1992-06-29
MODIFIED ORTHO EBV VCA-IGG ELISA (K920412)Ortho Diagnostic Systems, Inc.1992-06-22
BACTIDROP INDOLE (ERLICH'S) (K920973)Remel Co.1992-06-19
URINE CULTUR STABILIZATION TRANSPORT TUBE (K920761)Bio Medicus, Inc.1992-06-19
PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION (K922010)Alexon, Inc.1992-06-19
DRYSLIDE(TM), PYR (K921583)Difco Laboratories, Inc.1992-06-19
TB SUSCEPTIBILITY QUADS I AND II (K920143)Remel Co.1992-06-09
SEROELISA(TM) CHLAMYDIA IGA TEST KIT (K914327)Savyon Diagnostics , Ltd.1992-06-09
AUTOSCEPTOR IDENTIFICATION SYSTEM (K920225)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-05-22
BACTIDROP NINHYDRIN (K920971)Remel Co.1992-05-22
BACTIDROP PYR (K920972)Remel Co.1992-05-22
PHADEBACT MONOCLONAL GC TEST, MODIFICATION (K921075)Karo Bio Diagnostics AB1992-05-22
AZITHROMYCIN, 15 MCG, SENSI DISC (K921420)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-05-08
MAXAQUIN (K921282)Difco Laboratories, Inc.1992-05-06
M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION) (K921472)Microtest1992-05-06
CAPTIA CMV-TA (K915479)Mercia Diagnostics , Ltd.1992-05-04
RUBALEX, MODIFICATION (K912391)Orion Corp.1992-05-04
CHAGAS' IGG ELISA TEST (K911233)Gull Laboratories, Inc.1992-05-04
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS (K920378)Gen-Probe, Inc.1992-04-29
ENZYGNOST(R) TOXOPLASMOSIS/IGG (K913731)Behring Diagnostics, Inc.1992-04-29
ENZYGNOST(R) ANTI-CMV IGG (K913910)Behring Diagnostics, Inc.1992-04-28
LOMEFLOXACIN, 10 MCG, SENSI DISC (K921193)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-27
BACT/ALERT PEDI-BACT (K920249)Organon Teknika Corp.1992-04-23
RUBELLA IGM ELISA TEST SYSTEM (K914028)Zeus Scientific, Inc.1992-04-22
BACTEC 9240 SYSTEM (K915796)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-22
NIACIN CONTROL DISKS (K920257)Remel Co.1992-04-22
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA (K921133)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-22
ORTHO HSV ANTIGEN ELISA TEST (K915551)Ortho Diagnostic Systems, Inc.1992-04-22
MODIFICATION PROSPECT GIARDIA RAPID ASSAY (K920817)Alexon, Inc.1992-04-22
ALBICANS SURE (K913426)Jrga Diagnostics1992-04-22
BACTEC FOS CULTURE SUPPLEMENT (K920933)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-17
LORACARBEF 30MCG, SENSI DISC (K920786)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-08
IMMUNODOT BORRELIA (LYME) TEST (K911627)General Biometrics, Inc.1992-04-08
CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT (K915454)Medical Packaging Corp.1992-04-08
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (K920416)Behring Diagnostics, Inc.1992-04-08
TEMAFLOXCIN, 5MCG, SENSI DISC (K920787)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-08
ACCUPACE GROUP A STREPTOCOCCUS ID TEST (K915852)Gen-Probe, Inc.1992-04-02
CEFPROZIL 30MCG, SENSI DISC (K920473)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-03-23
SEROLISA CHLAMYDIA IGG TEST KIT (K915281)Savyon Diagnostics , Ltd.1992-03-23
BBL STREP GROUPING KIT (K920565)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-03-23
PROSPECT(TM/CRYPTOSPORIDIUM (K912242)Alexon, Inc.1992-03-23
OPUS RUBELLA TEST SYSTEM (K915870)Pb Diagnostics, Inc.1992-03-23
DIRECTIGEN MENINGITIS COMBO TEST KIT (K915330)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-03-23
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (K915053)Beckman Instruments, Inc.1992-03-19
VIRATEST-DIA(TM) MEASLES (RUBEOLA) (K910290)Virus Reference Laboratory, Inc.1992-03-18
DIRECTIGEN NEISSERIA MENINGITIDIS TEST (K920274)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-03-18
RUBELLA IGG ELISA TEST (K915893)Gull Laboratories, Inc.1992-03-04
VIDAS CHLAMYDIA ASSAY, MODIFICATION (K915884)Vitek Systems, Inc.1992-03-04
ELISA CMV IGM (K914789)Sclavo, Inc.1992-03-04
CLOSTRIDIUM DIFFICILE TOX-A-TEST (K914902)Techlab, Inc.1992-03-04
TOXO IGG ELISA TEST (MODIFIED) (K915891)Gull Laboratories, Inc.1992-03-04
ENZYGNOST TOXOPLASMOSIS/IGM (K913505)Behring Diagnostics, Inc.1992-03-04
GAP IGG H.PYLORI MODIFIED (K915185)Biomerica, Inc.1992-03-04
KALLESTAD ROTAVIRUS MICROPLATE (K915137)Bio-Rad Laboratories, Inc.1992-03-04
RAMBACH AGAR (K912924)Rantran, Inc.1992-02-28
ENZYGNOST(R) ANTI-CMV/IGM (K913693)Behring Diagnostics, Inc.1992-02-27
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) (K915851)Quidel Corp.1992-02-21
IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (K914953)Stellar Bio Systems, Inc.1992-02-19
HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE (K912778)Sensititre Microbiology A Div. of Radiometer1992-02-18
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