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

    I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)

    K Number: K053597 · Decision Jul 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    44
    Applicant Total
    7
    Review Days
    210

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    Basic Information

    Device Name
    I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
    K Number
    K053597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1117
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Stat Corporation
    Date Received
    December 23, 2005
    Decision Date
    July 21, 2006
    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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