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

    IL TEST HEPARIN (XA), PN 84699-15

    K Number: K935212 · Decision Feb 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    45
    Applicant Total
    300
    Review Days
    101

    Basic Information

    Device Name
    IL TEST HEPARIN (XA), PN 84699-15
    K Number
    K935212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INSTRUMENTATION LABORATORY CO.
    Date Received
    October 29, 1993
    Decision Date
    February 7, 1994
    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 INSTRUMENTATION LABORATORY CO.

    K Number Device Name
    K170314 ACL AcuStar
    K160225 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
    K160885 HemosIL D-Dimer HS
    K153137 HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
    K160445 HemosIL Silica Clotting Time
    K160276 ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
    K151534 HemosIL D-Dimer HS
    K133005 HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
    K132722 HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
    K133407 GEM PREMIER 4000
    Search all 300 clearances from INSTRUMENTATION LABORATORY CO. →