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

    REAGENT, CHLORIDOMETER ACID

    K Number: K760394 · Decision Nov 1, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    REAGENT, CHLORIDOMETER ACID
    K Number
    K760394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bulcher Instruments
    Date Received
    August 6, 1976
    Decision Date
    November 1, 1976
    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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