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

    BILIRUBIN STANDARD

    K Number: K882059 · Decision Oct 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    14
    Review Days
    162

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    Basic Information

    Device Name
    BILIRUBIN STANDARD
    K Number
    K882059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Verichem Laboratories, Inc.
    Date Received
    May 16, 1988
    Decision Date
    October 25, 1988
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

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    K924904 HDL-CHOLESTEROL STANDARD, MODIFICATION
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    K901113 MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
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