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

    ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES

    K Number: K841532 · Decision May 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    20
    Applicant Total
    253
    Review Days
    16

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    Basic Information

    Device Name
    ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES
    K Number
    K841532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3910
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    April 16, 1984
    Decision Date
    May 2, 1984
    Product Code
    LFG
    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
    LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

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    Other Clearances by E.I. Dupont DE Nemours & Co., Inc.

    K Number Device Name
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    K953725 CRONEX RADIATION THERAPY VERIFICATION CASSETTE
    K953724 CRONEX RADIATION THERAPY CASSETTE
    K951441 DUPONT ACA DIGOXIN (DGN A) METHOD
    K950137 URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950136 URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950181 URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950135 URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950182 URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950134 URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
    Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →