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

    ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS

    K Number: K072658 · Decision Apr 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    69
    Applicant Total
    11
    Review Days
    194

    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
    ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
    K Number
    K072658
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions Diagnostics
    Date Received
    September 20, 2007
    Decision Date
    April 1, 2008
    Product Code
    DCN
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DCN System, Test, C-Reactive Protein

    Similar 510(k) Clearances

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

    CardioPhase® hsCRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    RCRP Flex reagent cartridge

    FDA 510(k)
    FDA Class 2 ·Immunology

    Tina-quant C-Reactive Protein IV

    FDA 510(k)
    FDA Class 2 ·Immunology

    Optilite High Sensitivity C-Reactive Protein Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

    FDA 510(k)
    FDA Class 2 ·Immunology

    MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

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

    Other Clearances by Siemens Medical Solutions Diagnostics

    K Number Device Name
    K100910 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
    K091984 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
    K081895 ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
    K071455 ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
    K073537 NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
    K072794 IMMULITE 2500 OM-MA, MODEL L5KOP
    K071466 DCA VANTAGE, MODEL 5075
    K072204 ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
    K070727 ADVIA CHEMISTRY ENZYMATIC CREATININE_2
    K071017 IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
    Search all 11 clearances from Siemens Medical Solutions Diagnostics →