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

    CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95

    K Number: K863478 · Decision Oct 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    12
    Applicant Total
    288
    Review Days
    50

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    Basic Information

    Device Name
    CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
    K Number
    K863478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    September 9, 1986
    Decision Date
    October 29, 1986
    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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