BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY

    K Number: K071587 · Decision Jul 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
    K Number
    K071587
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inverness Medical Innovations, Inc.
    Date Received
    June 11, 2007
    Decision Date
    July 30, 2007
    Product Code
    JJX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

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    Other Clearances by Inverness Medical Innovations, Inc.

    K Number Device Name
    K071265 SMARTCHECK INR SYSTEM
    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