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Microbiology

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

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RecordFirmDate
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST (K911570)Ortho Diagnostic Systems, Inc.1991-06-10
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (K911571)Ortho Diagnostic Systems, Inc.1991-06-10
LYME DISEASE MICROASSAY (K910899)Diamedix Corp.1991-06-10
EIA FOR DETECTION OF ANTIBODIES H. PYLORI (K905409)E-Z-Em, Inc.1991-06-10
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST (K911569)Ortho Diagnostic Systems, Inc.1991-06-10
TURBIDOMETRIC STANDARD (K911059)Scientific Device Laboratory, Inc.1991-06-10
HSV-1 IGG ELISA TEST (K910954)Gull Laboratories, Inc.1991-05-28
HSV-2 IGG ELISA TEST (K910952)Gull Laboratories, Inc.1991-05-28
HSV-2 IGM ELISA TEST (K910953)Gull Laboratories, Inc.1991-05-28
HSV-1 IGM ELISA TEST (K910955)Gull Laboratories, Inc.1991-05-28
TARGET ASO TEST (K910073)Texas Immunology, Inc.1991-05-21
ENZYGNOST ANTI-CMV/IGG + IGM (K901485)Behring Diagnostics, Inc.1991-05-20
ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN (K911558)Alamar Biosciences Laboratory, Inc.1991-05-15
BACTI-SWAB (K910180)Remel Co.1991-05-10
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST (K911145)Medical Diagnostic Technologies, Inc.1991-05-10
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN (K911392)Alamar1991-05-08
ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME) (K911391)Alamar1991-05-08
ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM) (K911390)Alamar1991-05-08
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM) (K911389)Alamar1991-05-08
MODIFIED PK TP CONTROL (K911266)Olympus Corp.1991-05-07
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR (K905049)Quidel Corp.1991-05-07
PYLORI STAT TEST KIT (K904738)Whittaker Bioproducts, Inc.1991-05-07
PYLORI-G FIAX TEST KIT (K905468)Whittaker Bioproducts, Inc.1991-05-07
OLYMPUS PK-TP ABSORBENT KIT (K905038)Fujirebio America, Inc.1991-05-06
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS (K910499)Vitek Systems, Inc.1991-05-01
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST (K905787)Vitek Systems, Inc.1991-04-29
RUBENOSTIKA IGG MICROELISA SYSTEM (K911393)Organon Teknika Corp.1991-04-29
ANTIMICROBIAL GENTAMICIN (K911305)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL TOBRAMYCIN (K911304)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL. (K911556)Alamar Biosciences Laboratory, Inc.1991-04-22
ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL. (K911555)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN (K911557)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID (K911559)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL AMPICILLIN (K911185)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL AMIKACIN (K911303)Alamar Biosciences Laboratory, Inc.1991-04-18
QUIDEL HELICOBACTER PYLORI TEST (K903099)Quidel Corp.1991-04-17
ANTIMICROBIAL AMPICILLIN/SULBACTAM (K911186)Alamar Biosciences Laboratory, Inc.1991-04-17
ANTIMICROBIAL CEFUROXIME (K911187)Alamar Biosciences Laboratory, Inc.1991-04-17
OPUS CMV TEST SYSTEM (K905257)Pb Diagnostic Systems, Inc.1991-04-17
VISI-STREP (K910537)Kev Connecticut Diagnostics, Inc.1991-04-12
EBV IGG ELISA TEST (K910872)Gull Laboratories, Inc.1991-04-12
MICROTEST MULTI MICROBE MEDIUM (K910526)Microtest1991-04-09
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION (K910666)Vitek Systems, Inc.1991-04-03
CYTOMEGALOVIRUS (CMV) ELISA (K904456)Virotech, Inc.1991-04-03
VISI-STAPH (K905617)Connecticut Diagnostics, Ltd.1991-03-29
STREPTEX ACID EXTRACTION KIT (K910797)Wellcome Diagnostics1991-03-29
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K904189)Ciba Corning Diagnostics Corp.1991-03-27
TRICHINELLA SEROLOGY MICROTITER ELISA (K904613)Lmd Laboratories1991-03-21
P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905385)Virion (U.S.), Inc.1991-03-21
CYTOMEGALOVIRUS ANTIBODY SCREEN (K910003)Immucor, Inc.1991-03-20
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION (K910668)Ortho Diagnostic Systems, Inc.1991-03-19
IPAZYME (TM) CHLAMYDIA IGG-IGA (K910644)Savyon Diagnostics , Ltd.1991-03-19
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (K904329)Baxter Healthcare Corp1991-03-12
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION (K905179)Syva Co.1991-03-12
BACT/ALERT (TM) (K903505)Organon Teknika Corp.1991-03-12
BACTEC NR-860 (K910835)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-03-11
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K910484)Alamar1991-03-11
IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) (K901975)Savyon Diagnostics , Ltd.1991-03-08
EF SYNERGY QUAD MODIFIED (K910242)Remel Co.1991-03-05
OFLOXACIN, 5 MCG SENSI-DISC (K910506)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-03-04
FLOXIN SUSCEPTIBILITY TEST DISKS (K910412)Difco Laboratories, Inc.1991-02-27
LAP DISCS (K905472)Carr-Scarborough Microbiologicals, Inc.1991-02-27
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM (K904501)Medical Diagnostic Technologies, Inc.1991-02-26
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL (K910416)Abbott Laboratories1991-02-26
SLIDEX ROTA-KIT 2 (K895805)Vitek Systems, Inc.1991-02-26
M. CAT. BUTYRATE DISC (K905666)Carr-Scarborough Microbiologicals, Inc.1991-02-26
ANTIMICROBIAL CEFOPERAZONE (K910345)Alamar1991-02-25
ANTIMICROBIAL CEFTRIAXONE (K910346)Alamar1991-02-25
EBV IGM ELISA TEST (K910042)Gull Laboratories, Inc.1991-02-21
NITRATE DISK (K905163)Remel Co.1991-02-20
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS (K904689)Alamar Biosciences Laboratory, Inc.1991-02-07
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K905853)Alamar Biosciences Laboratory, Inc.1991-02-07
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (K904095)California Integrated Diagnostics, Inc.1991-02-01
MERISTAR-MP (K905493)Meridian Diagnostics, Inc.1991-01-30
RAPITEX(R) ASL NEW (K903854)Behring Diagnostics, Inc.1991-01-28
SLIDEX STREPTO-KIT (K905020)Vitek Systems, Inc.1991-01-28
RHEUMAGEN ASO T-CONTROL (K904311)Biokit USA, Inc.1991-01-25
PREMIER-CRYPTOCOCCAL ANTIGEN (K904393)Meridian Diagnostics, Inc.1991-01-25
VANCOMYCIN DISK-5 MCG (K905151)Remel Co.1991-01-25
LUPUS(LE)-LATEX TEST (K905531)Immco Diagnostics, Inc.1991-01-25
E. COLI 0157 LATEX TEST (K903714)Pro-Lab, Inc.1991-01-24
GASTRO-INTESTINAL ACCU-CULSHURE TM (K903638)Medical Laboratory Automation Systems, Inc.1991-01-18
KODAK SURECELL(TM) STREP A CONTROL FLUID SET (K904589)Eastman Kodak Company1991-01-18
CHLAMYDIA SYSTEM SOFTWARE (CSS) (K904725)Kallestad Diag, A Div. of Erbamont, Inc.1991-01-14
DCL SYPHILIS-M CATALOG NO. 600-80 (K895964)Diagnostic Chemicals, Ltd. (Usa)1991-01-08
RUBEOLA IGM ELISA TEST (K904083)Gull Laboratories, Inc.1991-01-03
MEASLES IGG MICROASSAY (K903961)Diamedix Corp.1990-12-28
CAPTIA(R) SYPHILIS M, MODIFICATION (K904524)Mercia Diagnostics , Ltd.1990-12-26
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (K895965)Diagnostic Chemicals, Ltd. (Usa)1990-12-26
INDX DIP S TICKS (K901597)Intercare Diagnostics, Inc.1990-12-21
SEROFAST (K903958)Intl. Mycoplasma/Mdc Assoc.1990-12-21
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED (K904523)Alamar Biosciences Laboratory, Inc.1990-12-21
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF (K903132)Ortho Diagnostic Systems, Inc.1990-12-21
TOXO-CUBE (K903968)Difco Laboratories, Inc.1990-12-18
SAF FIXATIVE (K905120)Gibson Laboratories, Inc.1990-12-17
ORTHO CMV-M ANTIBODY ELISA TEST (K905077)Ortho Diagnostic Systems, Inc.1990-12-17
ORTHO CMV-G ANTIBODY ELISA TEST (K905078)Ortho Diagnostic Systems, Inc.1990-12-17
CMV IGM ELISA TEST (K903807)Gull Laboratories, Inc.1990-12-17
3M IGG FASTLYME(TM) TEST (K895713)3M Company1990-12-14
QUALTURE (K903470)Future Medical Technologies Intl., Inc.1990-12-13
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