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

    RAICHEM(TM) CREATINE KINASE-MB REAGENT

    K Number: K913398 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    63
    Review Days
    57

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    Basic Information

    Device Name
    RAICHEM(TM) CREATINE KINASE-MB REAGENT
    K Number
    K913398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Reagents Applications, Inc.
    Date Received
    July 30, 1991
    Decision Date
    September 25, 1991
    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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