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

    BUN REAGENT ASTRA 4 & 8 ANALYZERS

    K Number: K802518 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    23
    Review Days
    28

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    Basic Information

    Device Name
    BUN REAGENT ASTRA 4 & 8 ANALYZERS
    K Number
    K802518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nobel Scientific Industries, Inc.
    Date Received
    October 15, 1980
    Decision Date
    November 12, 1980
    Product Code
    CDN
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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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