BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    RAMP NT-PROBNP ASSAY

    K Number: K063662 · Decision Jul 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    44
    Applicant Total
    7
    Review Days
    591

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    Basic Information

    Device Name
    RAMP NT-PROBNP ASSAY
    K Number
    K063662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1117
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Response Biomedical Corp.
    Date Received
    December 8, 2006
    Decision Date
    July 21, 2008
    Product Code
    NBC
    Advisory Committee
    Clinical Chemistry
    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
    NBC Test, Natriuretic Peptide

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