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

    GSP Neonatal Total Galactose kit

    K Number: K190335 · Decision Nov 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    17
    Review Days
    265

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    Basic Information

    Device Name
    GSP Neonatal Total Galactose kit
    K Number
    K190335
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1310
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perkinelmer, Inc.
    Date Received
    February 14, 2019
    Decision Date
    November 6, 2019
    Product Code
    JIA
    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
    JIA Enzymatic Methods, Galactose

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