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

    ANALYZER, 100, BICHROMATIC, ABBOTT

    K Number: K780388 · Decision Mar 22, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    207
    Applicant Total
    448
    Review Days
    12

    Basic Information

    Device Name
    ANALYZER, 100, BICHROMATIC, ABBOTT
    K Number
    K780388
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    SYVA CO.
    Date Received
    March 10, 1978
    Decision Date
    March 22, 1978
    Product Code
    JJE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    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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