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

    CHLORIDE REAGENT

    K Number: K911297 · Decision Apr 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    52
    Applicant Total
    21
    Review Days
    22

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    Basic Information

    Device Name
    CHLORIDE REAGENT
    K Number
    K911297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Intersect Systems, Inc.
    Date Received
    March 25, 1991
    Decision Date
    April 16, 1991
    Product Code
    CHJ
    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
    CHJ Mercuric Thiocyanate, Colorimetry, Chloride

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    Other Clearances by Intersect Systems, Inc.

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