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

    UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS

    K Number: K884693 · Decision Dec 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    3
    Review Days
    36

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    Basic Information

    Device Name
    UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS
    K Number
    K884693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biomedical Research & Development Laboratories, Inc.
    Date Received
    November 9, 1988
    Decision Date
    December 15, 1988
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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