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

    CHOLESTECH BUN/CREATININE TEST SYSTEM

    K Number: K972012 · Decision Jul 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    20
    Review Days
    55

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    Basic Information

    Device Name
    CHOLESTECH BUN/CREATININE TEST SYSTEM
    K Number
    K972012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cholestech Corp.
    Date Received
    May 30, 1997
    Decision Date
    July 24, 1997
    Product Code
    CDN
    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
    CDN Urease, Photometric, Urea Nitrogen

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