Cleared Traditional

DRI TM Tricyclics Serum Tox Assay

K213875 · Microgenics Corporation · Toxicology
Dec 2022
Decision
373d
Days
Class 2
Risk

About This 510(k) Submission

K213875 is an FDA 510(k) clearance for the DRI TM Tricyclics Serum Tox Assay, a U.v. Spectrometry, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFH), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on December 21, 2022, 373 days after receiving the submission on December 13, 2021. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K213875 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2021
Decision Date December 21, 2022
Days to Decision 373 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LFH — U.v. Spectrometry, Tricyclic Antidepressant Drugs
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3910

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