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

    ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL

    K Number: K991498 · Decision Jun 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    21
    Review Days
    48

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    Basic Information

    Device Name
    ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
    K Number
    K991498
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1310
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neometrics, Inc.
    Date Received
    April 29, 1999
    Decision Date
    June 16, 1999
    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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