BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.

    K Number: K882450 · Decision Jul 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    3
    Review Days
    44

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    Basic Information

    Device Name
    GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.
    K Number
    K882450
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diamond Sensor Systems
    Date Received
    June 14, 1988
    Decision Date
    July 28, 1988
    Product Code
    JJE
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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    Other Clearances by Diamond Sensor Systems

    K Number Device Name
    K873577 GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
    K871686 GEM-CRIT CHECK