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

    ISOSCREEN-CK CONFIRMATORY KIT

    K Number: K895870 · Decision Dec 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    296
    Review Days
    58

    Basic Information

    Device Name
    ISOSCREEN-CK CONFIRMATORY KIT
    K Number
    K895870
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    ROCHE DIAGNOSTIC SYSTEMS, INC.
    Date Received
    October 4, 1989
    Decision Date
    December 1, 1989
    Product Code
    JHY
    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
    JHY Colorimetric Method, Cpk Or Isoenzymes

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