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

    CHLORIDE/CARBON DIOXIDE REAGENT SET

    K Number: K781275 · Decision Aug 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    18
    Applicant Total
    23
    Review Days
    38

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    Basic Information

    Device Name
    CHLORIDE/CARBON DIOXIDE REAGENT SET
    K Number
    K781275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nobel Scientific Industries, Inc.
    Date Received
    July 24, 1978
    Decision Date
    August 31, 1978
    Product Code
    JFS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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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