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

    AMYLASE LTS

    K Number: K862640 · Decision Sep 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    41
    Review Days
    61

    Basic Information

    Device Name
    AMYLASE LTS
    K Number
    K862640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    ELECTRO-NUCLEONICS LABORATORIES, INC.
    Date Received
    July 10, 1986
    Decision Date
    September 9, 1986
    Product Code
    CJA
    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
    CJA Amyloclastic, Amylase

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