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

    NML CK-MB RIA

    K Number: K812759 · Decision Oct 19, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    24
    Review Days
    18

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    Basic Information

    Device Name
    NML CK-MB RIA
    K Number
    K812759
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nuclear Medical Laboratories, Inc.
    Date Received
    October 1, 1981
    Decision Date
    October 19, 1981
    Product Code
    JHX
    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
    JHX Fluorometric Method, Cpk Or Isoenzymes

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