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

    PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK

    K Number: K903914 · Decision Oct 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    12
    Applicant Total
    505
    Review Days
    40

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    Basic Information

    Device Name
    PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
    K Number
    K903914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    August 24, 1990
    Decision Date
    October 3, 1990
    Product Code
    JGQ
    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
    JGQ Turbidimetric, Total Protein

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