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

    ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY

    K Number: K883395 · Decision Sep 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    96
    Applicant Total
    8
    Review Days
    39

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    Basic Information

    Device Name
    ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
    K Number
    K883395
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Quantimetrix Medical Industries
    Date Received
    August 11, 1988
    Decision Date
    September 19, 1988
    Product Code
    JJT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJT Enzyme Controls (Assayed And Unassayed)

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