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

    CPK(CK) IN VITRO DIAG. REAGENT SET

    K Number: K813406 · Decision Dec 22, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    74
    Review Days
    15

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    Basic Information

    Device Name
    CPK(CK) IN VITRO DIAG. REAGENT SET
    K Number
    K813406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pointe Scientific, Inc.,
    Date Received
    December 7, 1981
    Decision Date
    December 22, 1981
    Product Code
    JHS
    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
    JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

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