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

    GAMMADAB B-HCG RADIOIMMUNOASSAY KIT

    K Number: K801409 · Decision Jul 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    206
    Review Days
    28

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    Basic Information

    Device Name
    GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
    K Number
    K801409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    June 16, 1980
    Decision Date
    July 14, 1980
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JHI Visual, Pregnancy Hcg, Prescription Use

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