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

    CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS

    K Number: K871677 · Decision May 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    41
    Review Days
    14

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    Basic Information

    Device Name
    CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS
    K Number
    K871677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Catachem, Inc.
    Date Received
    April 28, 1987
    Decision Date
    May 12, 1987
    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 Catachem, Inc.

    K Number Device Name
    K062503 CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
    K945408 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER
    K932871 UIBC FOR DISCREET RANDOM ACCESS ANALYZER
    K903341 MAGNESIUM
    K902326 AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
    K902877 TOTAL IRON FOR MANUAL/AUTOMATED
    K895748 BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
    K895821 URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS
    K894715 CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
    K894389 CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
    Search all 41 clearances from Catachem, Inc. →