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

    CK-NAC REAGENT

    K Number: K852000 · Decision May 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    33
    Review Days
    23

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    Basic Information

    Device Name
    CK-NAC REAGENT
    K Number
    K852000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Alpkem Corp.
    Date Received
    May 7, 1985
    Decision Date
    May 30, 1985
    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 Alpkem Corp.

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    K890332 RFA/2 RAPID FLOW ANALYZER W/COMPUTER
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    K890333 ALBUMIN REAGENT
    K883020 RFA-300 RAPID FLOW ANALYZER W/COMPUTER
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