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

    GDS ENZYMATIC SALICYLATE REAGENT

    K Number: K882038 · Decision Jun 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    28
    Applicant Total
    7
    Review Days
    39

    Basic Information

    Device Name
    GDS ENZYMATIC SALICYLATE REAGENT
    K Number
    K882038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3830
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    GDS TECHNOLOGY, LLC.
    Date Received
    May 16, 1988
    Decision Date
    June 24, 1988
    Product Code
    DKJ
    Advisory Committee
    Clinical Toxicology
    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
    DKJ Colorimetry, Salicylate

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    K911801 KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
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