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

    NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT

    K Number: K950481 · Decision Feb 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    44
    Review Days
    363

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    Basic Information

    Device Name
    NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
    K Number
    K950481
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1310
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Isolab, Inc.
    Date Received
    February 3, 1995
    Decision Date
    February 1, 1996
    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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