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

    I-CHROMA CRP TEST

    K Number: K062981 · Decision Jul 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    69
    Applicant Total
    1
    Review Days
    287

    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
    I-CHROMA CRP TEST
    K Number
    K062981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boditech Diagnostics, Inc.
    Date Received
    September 29, 2006
    Decision Date
    July 13, 2007
    Product Code
    DCN
    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
    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