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

    SMARTCHECK INR SYSTEM

    K Number: K071265 · Decision Nov 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    6
    Review Days
    207

    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
    SMARTCHECK INR SYSTEM
    K Number
    K071265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inverness Medical Innovations, Inc.
    Date Received
    May 7, 2007
    Decision Date
    November 30, 2007
    Product Code
    JPA
    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
    JPA System, Multipurpose For In Vitro Coagulation Studies

    Similar 510(k) Clearances

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

    STA Satellite Max®

    FDA 510(k)
    FDA Class 2 ·Hematology

    Automated Blood Coagulation Analyzer CN-Series (CN-6000)

    FDA 510(k)
    FDA Class 2 ·Hematology

    TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

    FDA 510(k)
    FDA Class 2 ·Hematology

    TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

    FDA 510(k)
    FDA Class 2 ·Hematology

    Citrated: K, KH, RTH, FFH

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACL TOP 970 CL

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

    Other Clearances by Inverness Medical Innovations, Inc.

    K Number Device Name
    K071587 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
    K060133 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
    K053196 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
    K011479 ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
    K011616 INDUO BLOOD GLUCOSE METER