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

    AUTOMATED IMMUNOPRECIPITIN METHOD/ICG

    K Number: K803272 · Decision Jan 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    48
    Review Days
    28

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    Basic Information

    Device Name
    AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
    K Number
    K803272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Icl Scientific
    Date Received
    December 29, 1980
    Decision Date
    January 26, 1981
    Product Code
    DFZ
    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
    DFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control

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