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

    ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR

    K Number: K071455 · Decision Sep 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    8
    Applicant Total
    11
    Review Days
    475

    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 CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
    K Number
    K071455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions Diagnostics
    Date Received
    May 25, 2007
    Decision Date
    September 11, 2008
    Product Code
    MKW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MKW Cyclosporine

    Similar 510(k) Clearances

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

    ARCHITECT CYCLOSPORINE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXSYM CYCLOSPORINE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    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
    K073537 NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
    K072658 ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
    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 →