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

    AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1

    K Number: K863719 · Decision Nov 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    30
    Applicant Total
    157
    Review Days
    51

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    Basic Information

    Device Name
    AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1
    K Number
    K863719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    September 23, 1986
    Decision Date
    November 13, 1986
    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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