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

    HEPARIN ACA ANALYTICAL TEST PACK

    K Number: K843201 · Decision Nov 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    253
    Review Days
    108

    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
    HEPARIN ACA ANALYTICAL TEST PACK
    K Number
    K843201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    August 14, 1984
    Decision Date
    November 30, 1984
    Product Code
    KFF
    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
    KFF Assay, Heparin

    Similar 510(k) Clearances

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

    HemosIL Liquid Anti-Xa

    FDA 510(k)
    FDA Class 2 ·Hematology

    INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls

    FDA 510(k)
    FDA Class 2 ·Hematology

    STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

    FDA 510(k)
    FDA Class 2 ·Hematology

    ENOXAPARIN TEST CARD

    FDA 510(k)
    FDA Class 2 ·Hematology
    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
    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. →