Cleared Traditional

Alinity c Tricyclic Antidepressants Reagent Kit

K231020 · Microgenics Corporation · Toxicology
Nov 2023
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K231020 is an FDA 510(k) clearance for the Alinity c Tricyclic Antidepressants Reagent Kit, a U.v. Spectrometry, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFH), submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on November 17, 2023, 221 days after receiving the submission on April 10, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K231020 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2023
Decision Date November 17, 2023
Days to Decision 221 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