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

    MODIFIED PARAMAX GLUCOSE REAGENT

    K Number: K873936 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    144
    Applicant Total
    505
    Review Days
    59

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    Basic Information

    Device Name
    MODIFIED PARAMAX GLUCOSE REAGENT
    K Number
    K873936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    September 25, 1987
    Decision Date
    November 23, 1987
    Product Code
    CFR
    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
    CFR Hexokinase, Glucose

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