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

    SALICYLATE STAT-PAK

    K Number: K813185 · Decision Nov 24, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    28
    Applicant Total
    5
    Review Days
    8

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    Basic Information

    Device Name
    SALICYLATE STAT-PAK
    K Number
    K813185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3830
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Clin Tech Diagnostics Corp.
    Date Received
    November 16, 1981
    Decision Date
    November 24, 1981
    Product Code
    DKJ
    Advisory Committee
    Clinical Toxicology
    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
    DKJ Colorimetry, Salicylate

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    Other Clearances by Clin Tech Diagnostics Corp.

    K Number Device Name
    K821969 ACETAMINOPHEN STAT-PAK REAGENT SET
    K820076 GLYCO-SEP REAGENT TEST SET
    K810235 ACETAMINOPHEN/SALICYLATE CONTROL
    K802432 GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.