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

    Tina-quant Transferrin ver.2 (urine application)

    K Number: K182095 · Decision Nov 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    14
    Review Days
    94

    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
    Tina-quant Transferrin ver.2 (urine application)
    K Number
    K182095
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations (Rdo)
    Date Received
    August 3, 2018
    Decision Date
    November 5, 2018
    Product Code
    DDG
    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
    DDG Transferrin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    Access sTfR

    FDA 510(k)
    FDA Class 2 ·Immunology

    Transferrin

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRANSFERRIN KIT FOR USE ON THE SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

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

    Other Clearances by Roche Diagnostics Operations (Rdo)

    K Number Device Name
    K193053 Tina-quant Hemoglobin A1cDx Gen.3
    K192072 Tina-quant C-Reactive Protein IV
    K183517 Ammonia II
    K171080 ALP IFCC Gen.2
    K160571 cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
    K162593 HDL-Cholesterol Gen.4
    K161817 Tina-quant Cystatin C Gen.2
    K160570 Creatine Kinase
    K152245 ONLINE TDM Vancomycin Gen.3
    K151578 Carbamazepine Gen 4
    Search all 14 clearances from Roche Diagnostics Operations (Rdo) →