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

    IMPACT 400 #1447X2

    K Number: K833067 · Decision Dec 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    10
    Review Days
    91

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    Basic Information

    Device Name
    IMPACT 400 #1447X2
    K Number
    K833067
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gilford
    Date Received
    September 8, 1983
    Decision Date
    December 8, 1983
    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 Gilford

    K Number Device Name
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    K853469 GILFORD IMMUNOGLOBULIN M REAGENT
    K853466 GILFORD C3 COMPLEMENT REAGENT
    K851202 GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
    K842500 DATA MGMT. SYSTEM
    K840120 ADVANTAGE
    K812787 EIA RUBELLA