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

    KLINAR REAGENT PAK, #36010

    K Number: K801892 · Decision Oct 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    52
    Review Days
    76

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    Basic Information

    Device Name
    KLINAR REAGENT PAK, #36010
    K Number
    K801892
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hi Chem, Inc.
    Date Received
    August 8, 1980
    Decision Date
    October 23, 1980
    Product Code
    JGT
    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
    JGT Flame Photometry, Sodium

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