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

    BUN (UREASE) REAGENT

    K Number: K781253 · Decision Aug 21, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    101
    Review Days
    31

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    Basic Information

    Device Name
    BUN (UREASE) REAGENT
    K Number
    K781253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Coulter Electronics, Inc.
    Date Received
    July 21, 1978
    Decision Date
    August 21, 1978
    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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