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

    J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.

    K Number: K801662 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    54
    Review Days
    57

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    Basic Information

    Device Name
    J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
    K Number
    K801662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    July 21, 1980
    Decision Date
    September 16, 1980
    Product Code
    DEP
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DEP Lambda, Peroxidase, Antigen, Antiserum, Control

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