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

    DUPONT ACA DIGOXIN (DGN A) METHOD

    K Number: K951441 · Decision Jun 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    84
    Applicant Total
    253
    Review Days
    64

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    Basic Information

    Device Name
    DUPONT ACA DIGOXIN (DGN A) METHOD
    K Number
    K951441
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    March 29, 1995
    Decision Date
    June 1, 1995
    Product Code
    KXT
    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
    KXT Enzyme Immunoassay, Digoxin

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    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
    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
    K950427 URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
    Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →