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

    ELAN ALKALINE PHOSPHATE REAGENT KIT

    K Number: K991387 · Decision May 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    123
    Applicant Total
    12
    Review Days
    28

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    Basic Information

    Device Name
    ELAN ALKALINE PHOSPHATE REAGENT KIT
    K Number
    K991387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elan Holdings, Inc.
    Date Received
    April 21, 1999
    Decision Date
    May 19, 1999
    Product Code
    CJE
    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
    CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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    Other Clearances by Elan Holdings, Inc.

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    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
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