BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT

    K Number: K851976 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    162

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    Basic Information

    Device Name
    HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT
    K Number
    K851976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Si Sero-Immuno Diagnostics, Inc.
    Date Received
    May 7, 1985
    Decision Date
    October 16, 1985
    Product Code
    GMM
    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
    GMM Antigens, Iha, Toxoplasma Gondii

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    Other Clearances by Si Sero-Immuno Diagnostics, Inc.

    K Number Device Name
    K851977 HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT