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

    BECKMAN CHOLINESTERASE REAGENT KIT

    K Number: K893583 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    98

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    Basic Information

    Device Name
    BECKMAN CHOLINESTERASE REAGENT KIT
    K Number
    K893583
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3240
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Beckman
    Date Received
    May 9, 1989
    Decision Date
    August 15, 1989
    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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