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Microbiology

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

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RecordFirmDate
ORTHO RUBELLA ELISA TEST SYSTEM (K822342)Ortho Diagnostic Systems, Inc.1983-03-17
AUTOMATED ELISA READER LBI 300 (K830227)Bionetic Laboratory Products1983-03-10
LBI-100 37DEGREES INCUBATOR (K830405)Bionetic Laboratory Products1983-03-10
HANDI-WASH (K823787)Dynatech Corp.1983-03-09
BACTIGEN-N. MENINGITIDIS (K823880)Armkel, LLC1983-03-09
MIDDLEBROOK 7H10 AGAR BASE-LOWPH (K823859)Gibco Laboratories Life Technologies, Inc.1983-03-08
FILDES ENRICHMENT SOLUTON (K830383)Gibco Laboratories Life Technologies, Inc.1983-03-08
UREA-PDA DISK (K830396)Remel Co.1983-03-08
MICRO STIX #011-010-5000 & HOLDER#5100 (K823833)Dynatech Corp.1983-03-08
SELECTIVE LEGIONELLA MEDIA (K823885)Gibco Laboratories Life Technologies, Inc.1983-03-08
NEISSERIA IDENTIFICATION DISCS (K830364)Oxoid U.S.A., Inc.1983-03-08
DIPCHEX DIP-SLIDE CULTURE SYS (K830252)Granite Diagnostics, Inc.1983-03-07
LEGIONELLA SELECTIVE SUPPLEMENTS (K830384)Gibco Laboratories Life Technologies, Inc.1983-03-07
MINIATURE ION SELECTIVE ELECTRODES (K830130)Ionetics, Inc.1983-03-07
BAC-T-SCREEN BACTERIURIA DETECTION DEV (K823850)Marion Laboratories, Inc.1983-03-01
ABBOTT LABORATORIES STREP A EIA (K823569)Abbott Laboratories1983-03-01
CVT VIRAL TRANSPORTS (K830250)Immulok, Inc.1983-02-28
CAMPY BLOOD AGAR PLATE (K830251)Granite Diagnostics, Inc.1983-02-28
LYSOSTAPHIN REAGENT SET (K830323)Remel Co.1983-02-28
DIRECT FA CONJUGATE FOR LEGIONELLA SPP (K822859)Zeus Technologies1983-02-16
CETUS CMV IHA (K822965)Cetus Corp.1983-02-15
MS-2 BACTERIAL IDENTI. SYS (K830099)Abbott Laboratories1983-02-15
BIGGY AGAR (K830082)bioMerieux, Inc.1983-02-10
SALMONELLA-SHIGELLA AGAR (K830065)bioMerieux, Inc.1983-02-10
BILE ESCULIN AZIDE AGAR (K830080)bioMerieux, Inc.1983-02-10
COLUMBIA SHEEP BLOOD AGAR 5% (K830075)bioMerieux, Inc.1983-02-09
BILE ESCULIN AGAR (K830081)bioMerieux, Inc.1983-02-09
NUTRIENT AGAR (K830068)bioMerieux, Inc.1983-02-09
MARTIN-LEWIS AGAR (K830062)bioMerieux, Inc.1983-02-09
MUELLER HINTON (K830060)bioMerieux, Inc.1983-02-09
LEVINE EMB AGAR (K830073)bioMerieux, Inc.1983-02-09
CONTACT PLATE LECITHIN & POLYSORBATE 80 (K830063)bioMerieux, Inc.1983-02-09
MUELLER HINTON W/50% SHEEP BLOOD (K830059)bioMerieux, Inc.1983-02-09
MANNITOL SALT AGAR (K830070)bioMerieux, Inc.1983-02-09
BISMUTH SULFITE AGAR (K830079)bioMerieux, Inc.1983-02-09
PHENYLETHANOL AGAR W/50% SHEEP BLOOD (K830067)bioMerieux, Inc.1983-02-09
MYCOBIOTIC AGAR (K830069)bioMerieux, Inc.1983-02-09
BRAIN HEART INFUSION AGAR (K830077)bioMerieux, Inc.1983-02-09
CHOCOLATE AGAR, ENRICHED (K830074)bioMerieux, Inc.1983-02-09
HEKTOEN ENTERIC AGAR (K830072)bioMerieux, Inc.1983-02-09
MACCONKEY AGAR (K830071)bioMerieux, Inc.1983-02-09
XLD AGAR (K830064)bioMerieux, Inc.1983-02-09
SABOURAND DEXTROSE AGAR (K830066)bioMerieux, Inc.1983-02-09
Q-CHECK CULTI-LOOPS (K830133)Lab Ability, Inc.1983-02-09
CAMPYLOCACTER SELECTIVE AGAR BLASER'S (K830076)bioMerieux, Inc.1983-02-09
THAYER-MARTIN, MODIFIED (K830061)bioMerieux, Inc.1983-02-09
BLOOD AGAR(TSA W/5% SHEEP BLOOD) (K830078)bioMerieux, Inc.1983-02-09
ACETAMIDE AGAR (K830020)Gibco Laboratories Life Technologies, Inc.1983-02-07
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP (K823718)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-02-07
Q-CHECK REAGENT STANDARDS (K830134)Lab Ability, Inc.1983-01-09
RAPID BACTERIURIA SCREENING TEST (K820126)Analytical Luminescence Laboratory, Inc.1983-01-07
ATS AFB STAIN CONTROL SLIDE (K823706)Alpha-Tec Systems, Inc.1983-01-07
ATS GRAM STAIN CONTROL SLIDE (K823704)Alpha-Tec Systems, Inc.1983-01-07
AZLOCILLIN 75MCG SENSI-DISC (K823800)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-01-07
ATS PARASITOLOGY STAIN CONTROL SLIDE (K823705)Alpha-Tec Systems, Inc.1983-01-07
GRAM NEGATIVE BACTERIAL IDENTIF- PANELS (K823738)Micro-Media Systems, Inc.1983-01-07
PHADEBACT CSF TEST 20 (K822810)Pharmacia, Inc.1982-12-30
H. INFLUENZA B ANTISERA FOR CIE (K823348)Diagnostica, Inc.1982-12-28
CORDIA CMV (K823123)Cordis Corp.1982-12-28
MOXALACTAM (K822866)Lilly Research Laboratories1982-12-28
CANDIDA DETECTION SYSTEM (K823016)Ramco Laboratories, Inc.1982-12-28
REMOVAWELL PLATE LID (K823557)Dynatech Corp.1982-12-28
STREPTACOCCUS CO-AGGLUTINATION KIT (K822799)American Scientific Products1982-12-19
STREPTOCOCCUS SELECTIVE AGAR (K823310)Troy Biologicals, Inc.1982-12-15
CAMPYLOBACTER SELECTIVE AGAR (K823307)Troy Biologicals, Inc.1982-12-15
HEMOPHILUS QUAD 10 PLATE (K823306)Troy Biologicals, Inc.1982-12-15
COLUMBIA V AGAR W/5% HUMAN BLOOD (K823311)Troy Biologicals, Inc.1982-12-15
MICRO TRAK CHLAMYDIA TRACHOMATIS CULT (K823010)Syva Co.1982-12-15
EBV IGM TEST (K822734)Gull Laboratories, Inc.1982-12-09
ANTIBODY TO MUMPS VIRUS IFA TEST (K822826)Electro-Nucleonics Laboratories, Inc.1982-12-03
MYCAREL AGAR MYCOBROTIC AGAR (K823308)Troy Biologicals, Inc.1982-12-03
HERPES TRANSETTE (K823443)Spectrum Diagnostic, Inc.1982-12-03
SCHAEDLER AGARS (K823248)Granite Diagnostics, Inc.1982-12-03
MYCOTRIUM-RS (K822737)Hana Biologics, Inc.1982-12-03
OCTAPETTES (K823137)Corning Costar Corp.1982-12-03
MYCOTRIUM-GU (K822736)Hana Biologics, Inc.1982-12-03
EBV-M KIT (K822985)Litton Bionetics1982-12-03
LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM (K823122)Granite Diagnostics, Inc.1982-12-03
AGAR P (K823102)Dms Laboratories1982-12-03
MARTIN & LEMIS AGAR W/VCAT INHIBITOR (K823309)Troy Biologicals, Inc.1982-12-03
SMITH'S MEDIUM (K823139)Granite Diagnostics, Inc.1982-12-03
FLUOROSET IMMUNOFLUORESCENT ANTIBODY (K822785)Immulok, Inc.1982-11-29
NYSTYMOGRAPH ACCESS (K823111)Kelleher Corp.1982-11-22
AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC (K822809)General Diagnostics1982-11-22
STREP SELECTIVE AGAR (K822997)Granite Diagnostics, Inc.1982-11-17
JORDANS TARTRATE AGAR (K822996)Granite Diagnostics, Inc.1982-11-16
ANDRADES FERMENTATION MEDIA (K822995)Granite Diagnostics, Inc.1982-11-16
PEPTONE IRON AGAR (K823001)Granite Diagnostics, Inc.1982-11-16
MICROFLUOR B PLATE & MICRO FLUOR W PLATE (K822960)Dynatech Corp.1982-11-16
CIN AGAR MEDIUM (K823050)Gibco Laboratories Life Technologies, Inc.1982-11-16
DISPOSABLE DISPENSE MANIFOLD (K823218)Dynatech Laboratories, Inc.1982-11-16
MACATE BROTH (K823000)Granite Diagnostics, Inc.1982-11-16
DNASE TEST AGAR W/TOLUIDINE BLUE (K822999)Granite Diagnostics, Inc.1982-11-16
CHRISTENSENS CITRATE SULFIDE AGAR (K822998)Granite Diagnostics, Inc.1982-11-16
CHLAMYDIA TRANSETTEE 1 & 3 (K823179)Spectrum Co.1982-11-16
MICROFLUOR B REMOVAWELL STRIPS (K822962)Dynatech Corp.1982-11-16
RAPID PRESUMPTIVE IDENT. GPA STREP (K823198)Microchemical Specialities, Co.1982-11-16
MICROTECH BACTERIAL CONTROLS (K822954)Universal Micro Reference Laboratory1982-11-16
CORN MEAL AGAR W/POLYSORBATE 80 (K822994)Granite Diagnostics, Inc.1982-11-16
BACTEC NAP TB DIFFERENTIATION TEST (K822946)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-11-12
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