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

    DURAZYME CPK

    K Number: K833781 · Decision Jan 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    73
    Review Days
    82

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    Basic Information

    Device Name
    DURAZYME CPK
    K Number
    K833781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Monitor Corp.
    Date Received
    October 28, 1983
    Decision Date
    January 18, 1984
    Product Code
    CGS
    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
    CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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    Other Clearances by American Monitor Corp.

    K Number Device Name
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    K893137 EXCEL (TM) CHEMISTRY ANALYZER
    K892331 ENZYMATIC UREA NITROGEN REAGENT SET
    K893479 CHOLESTEROL REAGENT SET
    K892002 NEOCHROME(R) III GLUCOSE
    K890312 GAMMA-GLUTAMYLTRANSFERASE
    K890034 PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)
    Search all 73 clearances from American Monitor Corp. →