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

    RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD

    K Number: K883389 · Decision Dec 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    16
    Applicant Total
    63
    Review Days
    126

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    Basic Information

    Device Name
    RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
    K Number
    K883389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Reagents Applications, Inc.
    Date Received
    August 10, 1988
    Decision Date
    December 14, 1988
    Product Code
    JIW
    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
    JIW Calibrator, Surrogate

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