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

    WAMPOLE HS-CRP ELISA

    K Number: K011855 · Decision Jan 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    69
    Applicant Total
    1
    Review Days
    209

    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
    WAMPOLE HS-CRP ELISA
    K Number
    K011855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carter-Wallace, Inc.
    Date Received
    June 13, 2001
    Decision Date
    January 8, 2002
    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