BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CARDIOZYME CK CONTROL NORMAL

    K Number: K770973 · Decision Aug 4, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    96
    Applicant Total
    44
    Review Days
    65

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    Basic Information

    Device Name
    CARDIOZYME CK CONTROL NORMAL
    K Number
    K770973
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    May 31, 1977
    Decision Date
    August 4, 1977
    Product Code
    JJT
    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
    JJT Enzyme Controls (Assayed And Unassayed)

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    Other Clearances by Dade, Baxter Travenol Diagnostics, Inc.

    K Number Device Name
    K800296 WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
    K792606 WHOLE BLOOD PLATELET CONTROL NORMAL,
    K792723 BLOOD FLUID FILTERS
    K792607 T3 UPTAKE (T3U) REAGENTS
    K792443 TSH RADIOIMMUNOASSAY
    K792442 FERRITIN RADIOIMMUNOASSAY
    K791922 HARLECO BRAND CLINICARD LIPASE TEST SET
    K792183 DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
    K790767 IMMU-TEK AUTOMATIC CENTRIFUGE
    K790776 DADE LOW IONIC STRENGTH SOLUITION (LISS)
    Search all 44 clearances from Dade, Baxter Travenol Diagnostics, Inc. →