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

    DRI-STAT ENZYMATIC BILIRUBIN TEST KIT

    K Number: K843174 · Decision Sep 14, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    281
    Review Days
    32

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    Basic Information

    Device Name
    DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
    K Number
    K843174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Beckman Instruments, Inc.
    Date Received
    August 13, 1984
    Decision Date
    September 14, 1984
    Product Code
    JFM
    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
    JFM Enzymatic Method, Bilirubin

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