BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    SENTINEL CHOLINESTERASE LIQUID

    K Number: K051444 · Decision Jun 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    25
    Applicant Total
    10
    Review Days
    18

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    Basic Information

    Device Name
    SENTINEL CHOLINESTERASE LIQUID
    K Number
    K051444
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.3240
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sentinel Ch. Srl
    Date Received
    June 2, 2005
    Decision Date
    June 20, 2005
    Product Code
    DIH
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    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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