BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHLORIDE REAGENT, CUP & CLEANER

    K Number: K800217 · Decision Feb 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    18
    Applicant Total
    89
    Review Days
    22

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    Basic Information

    Device Name
    CHLORIDE REAGENT, CUP & CLEANER
    K Number
    K800217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fisher Scientific Co., LLC
    Date Received
    February 4, 1980
    Decision Date
    February 26, 1980
    Product Code
    JFS
    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
    JFS Coulometric, Chloride

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