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

    ATAC PAK CPK REAGENT KIT

    K Number: K012474 · Decision Oct 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    12
    Review Days
    62

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    Basic Information

    Device Name
    ATAC PAK CPK REAGENT KIT
    K Number
    K012474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elan Holdings, Inc.
    Date Received
    August 2, 2001
    Decision Date
    October 3, 2001
    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 Elan Holdings, Inc.

    K Number Device Name
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    K000958 ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
    K000900 ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
    K992842 HICHEM ISE ELECTROLYTE REFERENCE
    K992844 HICHEM ISE ELECTROLYTE BUFFER
    K992846 HICHEM TOTAL PROTEIN REAGENT
    K992845 HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
    K992847 HICHEM BUN REAGENT
    K991789 ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
    Search all 12 clearances from Elan Holdings, Inc. →