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

    AUTOMATIC ANALYZER

    K Number: K771662 · Decision Dec 6, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    98

    Basic Information

    Device Name
    AUTOMATIC ANALYZER
    K Number
    K771662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    LACHAT CHEMICALS, INC.
    Date Received
    August 30, 1977
    Decision Date
    December 6, 1977
    Product Code
    JJC
    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
    JJC Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

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