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

    ACA FIBRINOGEN TEST PACK

    K Number: K812629 · Decision Oct 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    27
    Applicant Total
    253
    Review Days
    24

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    Basic Information

    Device Name
    ACA FIBRINOGEN TEST PACK
    K Number
    K812629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    September 14, 1981
    Decision Date
    October 8, 1981
    Product Code
    KQJ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KQJ System, Fibrinogen Determination

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

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    K953725 CRONEX RADIATION THERAPY VERIFICATION CASSETTE
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    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
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