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

    TITAN GEL CPK ISOENZYME SYSTEM

    K Number: K822124 · Decision Nov 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    20
    Applicant Total
    280
    Review Days
    105

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    Basic Information

    Device Name
    TITAN GEL CPK ISOENZYME SYSTEM
    K Number
    K822124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    July 19, 1982
    Decision Date
    November 1, 1982
    Product Code
    JHT
    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
    JHT Chromatographic Separation, Cpk Isoenzymes

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