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

    CK-NAC REAGENT

    K Number: K974833 · Decision Feb 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    21
    Review Days
    51

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    Basic Information

    Device Name
    CK-NAC REAGENT
    K Number
    K974833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intersect Systems, Inc.
    Date Received
    December 24, 1997
    Decision Date
    February 13, 1998
    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 Intersect Systems, Inc.

    K Number Device Name
    K021636 ALBUMIN REAGENT
    K011972 DIRECT BILIRUBIN REAGENT
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    K003892 TOTAL BILIRUBIN REAGENT
    K983937 DUAL VIAL CREATININE REAGENT
    K941807 INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT
    K932888 INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
    K934039 INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
    K932267 ENZYMATIC CO2 REAGENT, MODIFICATION
    K913225 URINE/CSF MICROPROTEIN REAGENT
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