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

    DRI TM Tricyclics Serum Tox Assay

    K Number: K213875 · Decision Dec 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    21
    Review Days
    373

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    Basic Information

    Device Name
    DRI TM Tricyclics Serum Tox Assay
    K Number
    K213875
    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
    December 13, 2021
    Decision Date
    December 21, 2022
    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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