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

    ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

    K Number: K060133 · Decision Feb 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    6
    Review Days
    29

    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
    ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
    K Number
    K060133
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inverness Medical Innovations, Inc.
    Date Received
    January 18, 2006
    Decision Date
    February 16, 2006
    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)

    Similar 510(k) Clearances

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

    Beta-CrossLaps CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Elecsys CYFRA 21-1 CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Multichem A1c

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity DROP LQ Blood Glucose

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON CMV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON EBV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·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
    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