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

    RIA/MAT FPA TEST KIT

    K Number: K884496 · Decision Nov 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    RIA/MAT FPA TEST KIT
    K Number
    K884496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5350
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Altana, Inc.
    Date Received
    October 25, 1988
    Decision Date
    November 16, 1988
    Product Code
    DAN
    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
    DAN Fibrinopeptide A, Antigen, Antiserum, Control

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    Other Clearances by Altana, Inc.

    K Number Device Name
    K934205 SEARCH-SONIC