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

    CPK ISOENZYME REAGENT

    K Number: K791655 · Decision Sep 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    27
    Review Days
    27

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    Basic Information

    Device Name
    CPK ISOENZYME REAGENT
    K Number
    K791655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Electrophoresis Corp. of America
    Date Received
    August 21, 1979
    Decision Date
    September 17, 1979
    Product Code
    JHY
    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
    JHY Colorimetric Method, Cpk Or Isoenzymes

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    Other Clearances by Electrophoresis Corp. of America

    K Number Device Name
    K802396 GENERAL PROCEDURE AGAROSE FILM
    K792548 ALKALINE PHOSPHATASE MARKER
    K792547 AGAROSE BARBITAL BUFFER
    K792551 ALKALINE PHOSPHATASE REAGENT
    K792553 AGAROSE BARBITAL-EDTA BUFFER
    K792574 MOPSO BUFFER
    K792550 PONCEAU S STAIN SET
    K792549 FAT RED 7B STAIN SET
    K792552 AMIDO BLACK 10B STAIN
    K791656 ENZYME STABILIZING REAGENT (ESR)
    Search all 27 clearances from Electrophoresis Corp. of America →