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

    ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)

    K Number: K881894 · Decision Jul 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
    K Number
    K881894
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3020
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Cambridge Bioscience Corp.
    Date Received
    May 5, 1988
    Decision Date
    July 8, 1988
    Product Code
    GOD
    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
    GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33

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