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

    ACA IMMUNOGLOBIN M TEST PACK

    K Number: K812632 · Decision Sep 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    253
    Review Days
    14

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    Basic Information

    Device Name
    ACA IMMUNOGLOBIN M TEST PACK
    K Number
    K812632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    September 15, 1981
    Decision Date
    September 29, 1981
    Product Code
    DFT
    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
    DFT Igm, Antigen, Antiserum, Control

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