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

    AMERLITE FREE THYROID CONTROL SERA LAN.4002

    K Number: K920940 · Decision Apr 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    238
    Review Days
    50

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    Basic Information

    Device Name
    AMERLITE FREE THYROID CONTROL SERA LAN.4002
    K Number
    K920940
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eastman Kodak Company
    Date Received
    February 27, 1992
    Decision Date
    April 17, 1992
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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