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

    REAGIN ANTIGEN SUSPENSION

    K Number: K822662 · Decision Sep 21, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    31
    Applicant Total
    93
    Review Days
    18

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    Basic Information

    Device Name
    REAGIN ANTIGEN SUSPENSION
    K Number
    K822662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3820
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    September 3, 1982
    Decision Date
    September 21, 1982
    Product Code
    GMQ
    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
    GMQ Antigens, Nontreponemal, All

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