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

    TORCH BIO-BEAD SCREEN KIT

    K Number: K791618 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    17
    Applicant Total
    15
    Review Days
    85

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    Basic Information

    Device Name
    TORCH BIO-BEAD SCREEN KIT
    K Number
    K791618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Litton Bionetics
    Date Received
    August 20, 1979
    Decision Date
    November 13, 1979
    Product Code
    GLZ
    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
    GLZ Antigens, If, Toxoplasma Gondii

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