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

    ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)

    K Number: K053196 · Decision Dec 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
    K Number
    K053196
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inverness Medical Innovations, Inc.
    Date Received
    November 16, 2005
    Decision Date
    December 16, 2005
    Product Code
    NJV
    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
    NJV Test, Albumin Cobalt Binding

    Similar 510(k) Clearances

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

    ALBUMIN COBALT BINDING TEST (ACB TEST)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Inverness Medical Innovations, Inc.

    K Number Device Name
    K071265 SMARTCHECK INR SYSTEM
    K071587 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
    K060133 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
    K011479 ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
    K011616 INDUO BLOOD GLUCOSE METER