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

    ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD

    K Number: K911725 · Decision Jun 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    253
    Review Days
    47

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    Basic Information

    Device Name
    ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
    K Number
    K911725
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    April 17, 1991
    Decision Date
    June 3, 1991
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

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

    K Number Device Name
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    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. →