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

    BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

    K Number: K050367 · Decision May 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    6
    Review Days
    464

    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
    BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
    K Number
    K050367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hyphen Biomed
    Date Received
    February 14, 2005
    Decision Date
    May 24, 2006
    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

    ENOXAPARIN TEST CARD

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACTICHROME HEPARIN (ANTI-FIIA)

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Hyphen Biomed

    K Number Device Name
    K071255 ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
    K050365 BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
    K051472 BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
    K043007 BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
    K043451 BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR