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

    BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

    K Number: K043007 · Decision Nov 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    6
    Review Days
    371

    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 ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
    K Number
    K043007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hyphen Biomed
    Date Received
    November 1, 2004
    Decision Date
    November 7, 2005
    Product Code
    JBQ
    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
    JBQ Antithrombin Iii Quantitation

    Similar 510(k) Clearances

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

    INNOVANCE Antithrombin

    FDA 510(k)
    FDA Class 2 ·Hematology

    INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL ANTITHROMBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL LIQUID ANTITHROMBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL LIQUID ANTITHROMBIN XL

    FDA 510(k)
    FDA Class 2 ·Hematology

    CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50

    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
    K050367 BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
    K050365 BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
    K051472 BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
    K043451 BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR