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

    1F BLOCKING ANTIBODY(57 CO) RADIOASSAY

    K Number: K811927 · Decision Apr 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    111
    Review Days
    269

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    Basic Information

    Device Name
    1F BLOCKING ANTIBODY(57 CO) RADIOASSAY
    K Number
    K811927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    July 6, 1981
    Decision Date
    April 1, 1982
    Product Code
    LIG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIG Radioassay, Intrinsic Factor Blocking Antibody

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