BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACETAMINOPHEN/SALICYLATE CONTROL

    K Number: K810235 · Decision Feb 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    5
    Review Days
    13

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    Basic Information

    Device Name
    ACETAMINOPHEN/SALICYLATE CONTROL
    K Number
    K810235
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Clin Tech Diagnostics Corp.
    Date Received
    January 28, 1981
    Decision Date
    February 10, 1981
    Product Code
    DIF
    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
    DIF Drug Mixture Control Materials

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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
    K813185 SALICYLATE STAT-PAK
    K802432 GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.