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Microbiology

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

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RecordFirmDate
COLISTIN 10 MCG. DIFFERENTIAL DISK (K844381)Anaerobe Systems1985-01-04
LATEX-R RICKETTSII (K843794)Health Research, Inc.1985-01-04
BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT (K844370)Precision Dynamics Corp.1985-01-04
BILE DIFFERENTIAL DISK (K844380)Anaerobe Systems1985-01-04
EBNA ACIF KIT (K840417)Litton Bionetics1984-12-27
MIC-BIO-PLATE (K844903)Pasco Laboratories, Inc.1984-12-24
API UNISCEPT MIC 100UL (K844159)Analytical Products, Inc.1984-12-14
PYRIDOXAL DISC (K844020)Remel Co.1984-12-13
E-COLI-CHEK TUBE (K844276)E-Y Laboratories, Inc.1984-12-13
AMS ANA CARD (K843686)Vitek Systems, Inc.1984-12-12
ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) (K844141)Lmd Laboratories1984-12-06
BACTERIURIA DETECT DEVICE, MULTI SAMPLER (K843833)Applied Polytechnology, Inc.1984-11-29
BACTERIURIA DETECT. DEVICE APTEK II (K843834)Applied Polytechnology, Inc.1984-11-29
PHARMACIA STREP A DIRECT SWAB TEST (K844107)Pharmacia, Inc.1984-11-27
BIOTIS ANAEROBIC KBE AGAR (K844195)Otisville Biotech, Inc.1984-11-27
POS COMBO PANEL (K844086)American Micro Scan1984-11-13
SCEPTOR BETA-LACTAM PLUS MIC PANEL (K844231)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-07
ONO/CO-TWO (TM) SYSTEMS (K844014)Micro-Bio-Logics1984-10-31
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB (K843613)Immuno-Products Industries1984-10-31
STREP ID TRIPLATE (K844019)Remel Co.1984-10-31
DETECT-A-STREP (K843590)Antibodies, Inc.1984-10-30
ANTI-SCHISTOSOMA SPECIES KIT (K842660)Amico Lab, Inc.1984-10-30
PYR BROTH (K843987)Remel Co.1984-10-30
SCOTT SELECTICULT-HSV ISOLATION & (K841680)Scott Laboratories, Inc.1984-10-30
MYCOPLASMA PNEUMONIAE (K843664)Institute Virion , Ltd.1984-10-25
RPR TEST REDITEST (K843741)Biokit USA, Inc.1984-10-25
API UNISCEPT KB (K843733)Analytical Products, Inc.1984-10-24
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST (K843935)Syva Co.1984-10-23
PHENYLETHYL ALCOHOL AGAR PLATE (K834422)Otisville Biotech, Inc.1984-10-23
CAMPYLOCACTER SUPPLEMENT (K843653)Institute Virion , Ltd.1984-10-23
S S AGAR PLATE (K834423)Otisville Biotech, Inc.1984-10-23
MANNITOL-SALT AGAR USP PLATE (K834420)Otisville Biotech, Inc.1984-10-23
SFP AGAR PLATES (K834424)Otisville Biotech, Inc.1984-10-23
COLUMBIA CNA AGAR PLATE (K834419)Otisville Biotech, Inc.1984-10-23
ENZYGNOST ROTAVIRUS AG (K841243)Behring Diagnostics, Inc.1984-10-17
TOXOPLASMA GONDII IGM EIA TEST KIT (K842797)Labsystems, Inc.1984-10-17
BIOTIS MYCOLOGICAL MEDIA & SLANT (K843766)Otisville Biotech, Inc.1984-10-10
BIOTIS EMB AGAR HOLT-HARRIS (K843763)Otisville Biotech, Inc.1984-10-10
BIOTIS SCHAEDLER AGAR & BROTH (K843764)Otisville Biotech, Inc.1984-10-10
BIOTIS EMB-LEVINE AGAR (K843762)Otisville Biotech, Inc.1984-10-10
BIOTIS KLIGLER IRON AGAR (K843768)Otisville Biotech, Inc.1984-10-10
BIOTIS SEVEN H 11 AGAR (K843771)Otisville Biotech, Inc.1984-10-10
BIOTIS LOWENSTEIN-JENSEN MEDIA (K843769)Otisville Biotech, Inc.1984-10-10
BIOTIS MYCOBIOTIC AGAR (K843765)Otisville Biotech, Inc.1984-10-10
BIOTIS UREA AGAR (K843767)Otisville Biotech, Inc.1984-10-10
BIOTIS BIGGY AGAR & BIGGY SLANT (K843761)Otisville Biotech, Inc.1984-10-10
BIOTIS MARTIN LEWIS AGAR (K843817)Otisville Biotech, Inc.1984-10-10
ORTHO* RSV ANTIGEN ELISA TEST SYS (K842047)Ortho Diagnostic Systems, Inc.1984-10-05
NEOMYCIN BLOOD AGAR (K843492)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-10-02
DIFFERENTIATION DISKS NITRATE (K843521)Difco Laboratories, Inc.1984-10-02
AMIZYME-C TRACHOMATIS TEST KIT (K842525)Amico Lab, Inc.1984-10-01
EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (K843286)Immuno-Mycologics, Inc.1984-10-01
BACTO STAPHYLOCOCCUS LATEX TEST (K843560)Difco Laboratories, Inc.1984-10-01
RIM-UREA (K843571)Austin Biological Laboratories1984-10-01
ANTI-CHLAMYDIA TRACHOMATIS KIT (K842658)Amico Lab, Inc.1984-10-01
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK (K843341)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-27
URINE TRANSPORT KIT (K843359)Applied Polytechnology, Inc.1984-09-27
PHARMA-PLAST PETRI DISH (K843483)Zimmar Consulting , Ltd.1984-09-21
T.I.M.E. DISPENSER (K843272)Dynatech Laboratories, Inc.1984-09-14
STREP SELECTIVE II (K843193)Remel Co.1984-09-14
ROTALEX LATEX AGGLUTINATION TEST (K841319)Orion Diagnostica, Inc.1984-09-14
V AGAR SELECTIVE DEEPS (K843194)Remel Co.1984-09-14
APPLELISA CHLAMYDIA TRACHOMATIS ANTI (K843120)Apple Diagnostic Products1984-09-12
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (K842874)American Micro Scan1984-09-12
INDOLE SPOT TEST KIT 270-25 (K843316)Applied Polytechnology, Inc.1984-09-11
GIARDIA GUARD (K842052)Gelman Sciences, Inc.1984-09-11
AMIZYME-TOXOPLASMA GONDII KIT (K842528)Amico Lab, Inc.1984-09-07
CMV LATEX AGGLUTINATION TEST KIT (K841520)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-07
CODE-A-WELL 350 MICROTITRATION STRIPS (K842848)Plastic Injectors, Inc.1984-09-07
AUGMENTIN 30 MCG SENSITIVITY DISKS (K843172)Difco Laboratories, Inc.1984-09-07
DIFFERENTIATION DISKS BILE ESCULIN (K843364)Difco Laboratories, Inc.1984-09-07
CELL-MATICS VIRAL TRANSPORT PACK (K843173)Difco Laboratories, Inc.1984-09-06
AMIZYME-SCHISTOSOMA SPP. TEST KIT (K842527)Amico Lab, Inc.1984-09-05
AMIZYME-LEISHMANIA SPP. TEST KIT (K842526)Amico Lab, Inc.1984-08-28
ANTI-TOXOPLASMA GONDII KIT (K842664)Amico Lab, Inc.1984-08-28
SERIMM SURE ASO-CHEK CONTROL SERUM (K842839)Analytical Products, Inc.1984-08-23
AUGMENTIN 30 MCG SENSI DISC (K842253)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-23
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG (K843065)Otisville Biotech, Inc.1984-08-20
BIOTIS CIN AGAR PLATES (K843066)Otisville Biotech, Inc.1984-08-20
TRIPLE SUGAR IRON (K842850)Anarobe Systems1984-08-17
MUELLER HINTON BROTH (K842854)Anarobe Systems1984-08-17
STREPTEX DIRECT A ZL14 (K842827)Wellcome Diagnostics1984-08-16
STREPTEX ZL01 (K842828)Wellcome Diagnostics1984-08-15
ORTHO RESPIRATORY SYNCYTIAL VIRUS- (K841527)Ortho Diagnostic Systems, Inc.1984-08-12
ORNITHINE INDOLE MOTILITY (K842851)Anarobe Systems1984-08-07
HIPPURATE TEST REAGENT (K842871)Irvine Diagnostic Services1984-08-07
DECARBOXYLASE TEST REAGENT (K842869)Irvine Diagnostic Services1984-08-07
VOGES-PROSKAUER REAGENT A (K842870)Irvine Diagnostic Services1984-08-03
HIPPURATE TEST DISKS (K842868)Irvine Diagnostic Services1984-08-03
IMMUSTAPH LATEX AGGLUTINATION KIT (K842709)Immucell Corp.1984-08-03
BRAIN HEART INFUSION BROTH (K842852)Anarobe Systems1984-08-03
INDOLE REAGENT (K842872)Irvine Diagnostic Services1984-08-03
VOGES-PROSKAUER REAGENT B (K842867)Irvine Diagnostic Services1984-08-03
LYSINE IRON AGAR (K842853)Anarobe Systems1984-08-03
TRYPTICASE SOY BROTH (K842849)Anarobe Systems1984-08-03
CHRISTENSEN'S UREA AGAR (K842855)Anarobe Systems1984-08-03
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT (K842623)Syva Co.1984-08-02
GENETIC SYS LEGIONELLA IMMUNOFLURORES (K842683)Genetic Systems Corp.1984-08-02
B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (K842579)Biological & Environmental Control Laboratories1984-07-27
CEFONICID 30 MCG SENSITIVITY DISCS (K842292)Difco Laboratories, Inc.1984-07-26
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