BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OXIDE ANAEROBIC SYSTEM

    K Number: K800430 · Decision Apr 2, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    0
    Applicant Total
    93
    Review Days
    36

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    Basic Information

    Device Name
    OXIDE ANAEROBIC SYSTEM
    K Number
    K800430
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    February 26, 1980
    Decision Date
    April 2, 1980
    Product Code
    JTM
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTM Anaerobic Box Glove

    Other Clearances by Oxoid U.S.A., Inc.

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    K884208 LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
    K874303 STAPHYLASE TEST
    K872956 SORBITOL MACCONKEY AGAR NO. 3 CM 813
    K872135 MCBRIDE MEDIUM CM 819
    K870945 RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
    K862946 OXOID SIGNAL BLOOD CULTURE SYSTEM
    K855236 DIAGNOSTIC REAGENT TST-RPLA
    K855234 DIAGNOSTIC REAGENT VET-RPLA
    Search all 93 clearances from Oxoid U.S.A., Inc. →