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

    ACA URINE DRUGS OF ABUSE CONTROL

    K Number: K873539 · Decision Oct 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    253
    Review Days
    36

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    Basic Information

    Device Name
    ACA URINE DRUGS OF ABUSE CONTROL
    K Number
    K873539
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    September 1, 1987
    Decision Date
    October 7, 1987
    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 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
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    K950136 URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
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    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
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