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

    S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

    K Number: K130141 · Decision Mar 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    123
    Applicant Total
    16
    Review Days
    59

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    Basic Information

    Device Name
    S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
    K Number
    K130141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Chemical Diagnostics, Inc.
    Date Received
    January 22, 2013
    Decision Date
    March 22, 2013
    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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