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

    ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD

    K Number: K872391 · Decision Aug 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    253
    Review Days
    52

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    Basic Information

    Device Name
    ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD
    K Number
    K872391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    June 19, 1987
    Decision Date
    August 10, 1987
    Product Code
    DJG
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DJG Enzyme Immunoassay, Opiates

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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. →