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

    P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT

    K Number: K904761 · Decision Nov 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    321
    Review Days
    32

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    Basic Information

    Device Name
    P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
    K Number
    K904761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Laboratory CO
    Date Received
    October 19, 1990
    Decision Date
    November 20, 1990
    Product Code
    CIE
    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
    CIE Volumetric/Manometric, Carbon-Dioxide

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