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

    URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)

    K Number: K970277 · Decision Dec 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    9
    Review Days
    322

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    Basic Information

    Device Name
    URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
    K Number
    K970277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1315
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Astoria-Pacific, Inc.
    Date Received
    January 23, 1997
    Decision Date
    December 11, 1997
    Product Code
    KQP
    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
    KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

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