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

    IL TEST CHOLINESTERASE

    K Number: K943367 · Decision Feb 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    25
    Applicant Total
    321
    Review Days
    572

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    Basic Information

    Device Name
    IL TEST CHOLINESTERASE
    K Number
    K943367
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3240
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    July 13, 1994
    Decision Date
    February 5, 1996
    Product Code
    DIH
    Advisory Committee
    Clinical Toxicology
    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
    DIH Colorimetry, Cholinesterase

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