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

    Alinity c Tricyclic Antidepressants Reagent Kit

    K Number: K231020 · Decision Nov 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    21
    Review Days
    221

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    Basic Information

    Device Name
    Alinity c Tricyclic Antidepressants Reagent Kit
    K Number
    K231020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3910
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microgenics Corporation
    Date Received
    April 10, 2023
    Decision Date
    November 17, 2023
    Product Code
    LFH
    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
    LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs

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