BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEART CHECK APOLIPOPROTEIN-B

    K Number: K881433 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    HEART CHECK APOLIPOPROTEIN-B
    K Number
    K881433
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Northwest Biotech
    Date Received
    April 5, 1988
    Decision Date
    April 21, 1988
    Product Code
    MSJ
    Advisory Committee
    Clinical Chemistry
    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
    MSJ Apolipoproteins

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    Other Clearances by Northwest Biotech

    K Number Device Name
    K881434 HEART CHECK APOLIPOPROTEIN A-1