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

    URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE

    K Number: K950182 · Decision Mar 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    253
    Review Days
    63

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
    K Number
    K950182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    January 17, 1995
    Decision Date
    March 21, 1995
    Product Code
    DIW
    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
    DIW Hemagglutination Inhibition, Methadone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DIW), ordered by most recent decision date.

    ROCHE ABUSCREEN ONTRAK FOR METHADONE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HI-M-TEST FOR METHADONE TEST #2

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    KIT, METHADONE (TOXI-PAK IMMUNO HI)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

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

    K Number Device Name
    K951851 ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
    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
    K950134 URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
    K950427 URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
    Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →