BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GSP NEONATAL IRT KIT (3306-001U)

    K Number: K102419 · Decision Dec 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    113

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    Basic Information

    Device Name
    GSP NEONATAL IRT KIT (3306-001U)
    K Number
    K102419
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1725
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wallac Oy, Subsidiary of Perkinelmer
    Date Received
    August 25, 2010
    Decision Date
    December 16, 2010
    Product Code
    JNO
    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
    JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

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