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

    IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT

    K Number: K071002 · Decision Jun 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    18
    Applicant Total
    270
    Review Days
    73

    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
    IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
    K Number
    K071002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    April 9, 2007
    Decision Date
    June 21, 2007
    Product Code
    NQD
    Advisory Committee
    Immunology
    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
    NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

    Similar 510(k) Clearances

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

    Tina-quant Cardiac high sensitivity CRP III

    FDA 510(k)
    FDA Class 2 ·Immunology

    Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)

    FDA 510(k)
    FDA Class 2 ·Immunology

    CardioPhase® hsCRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    CRP Vario

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT

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

    Other Clearances by Beckman Coulter, Inc.

    K Number Device Name
    K252169 Access BNP II
    K254059 Access anti-HBc IgM
    K253687 Access anti-HBc Total
    K251995 Access anti-HAV IgM
    K250588 Access Rubella IgG
    K252580 iQ200 Series
    K243846 Access anti-HAV
    K243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
    K250036 MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
    K243483 Access hsTnI
    Search all 270 clearances from Beckman Coulter, Inc. →