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

    DSL CK-MB (DSL #3200)

    K Number: K904721 · Decision Dec 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    20
    Applicant Total
    94
    Review Days
    56

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    Basic Information

    Device Name
    DSL CK-MB (DSL #3200)
    K Number
    K904721
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    October 18, 1990
    Decision Date
    December 13, 1990
    Product Code
    JHT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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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