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

    GSP NEONATALGALT KIT, MODEL 3303-001U

    K Number: K100101 · Decision Jun 11, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    17
    Review Days
    149

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    Basic Information

    Device Name
    GSP NEONATALGALT KIT, MODEL 3303-001U
    K Number
    K100101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1315
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perkinelmer, Inc.
    Date Received
    January 13, 2010
    Decision Date
    June 11, 2010
    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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