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

    THERAPEUTIC DRUG CONTROL

    K Number: K833761 · Decision Jan 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    48
    Review Days
    79

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    Basic Information

    Device Name
    THERAPEUTIC DRUG CONTROL
    K Number
    K833761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Icl Scientific
    Date Received
    October 26, 1983
    Decision Date
    January 13, 1984
    Product Code
    DKB
    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
    DKB Calibrators, Drug Mixture

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    Other Clearances by Icl Scientific

    K Number Device Name
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    K843565 KOVA TROL I,II, III HUMAN URINE-DRIED
    K832823 ENZYMUNE-TEST TSH
    K831383 EVENT-TEST SLIDE
    K823199 ENZYME-TEST DIGOXIN
    K822346 HISTIMUNE ENZYME-ANA TEST
    K822777 THERAPEUTIC DRUG CONTROL
    K822465 ENZYMUNE SYSTEM I
    K821374 ENZYMUNE-TEST INSULIN
    K821097 SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA
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