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

    ACETAMINOPHEN STAT-PAK REAGENT SET

    K Number: K821969 · Decision Jul 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    35
    Applicant Total
    5
    Review Days
    15

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    Basic Information

    Device Name
    ACETAMINOPHEN STAT-PAK REAGENT SET
    K Number
    K821969
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3030
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Clin Tech Diagnostics Corp.
    Date Received
    July 1, 1982
    Decision Date
    July 16, 1982
    Product Code
    LDP
    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
    LDP Colorimetry, Acetaminophen

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    Other Clearances by Clin Tech Diagnostics Corp.

    K Number Device Name
    K820076 GLYCO-SEP REAGENT TEST SET
    K813185 SALICYLATE STAT-PAK
    K810235 ACETAMINOPHEN/SALICYLATE CONTROL
    K802432 GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.