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

    AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)

    K Number: K023396 · Decision Dec 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    30
    Applicant Total
    74
    Review Days
    75

    Basic Information

    Device Name
    AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
    K Number
    K023396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    POINTE SCIENTIFIC, INC.
    Date Received
    October 9, 2002
    Decision Date
    December 23, 2002
    Product Code
    CIJ
    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
    CIJ Saccharogenic, Amylase

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