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7 Tricyclic Antide Pressants

by Technicon Instruments Corp. 510(k)

Active United States

510(k) K802245

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802245 Date10 Oct 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LFI
Device Class
Class II
Regulation
21 CFR Part 862.3910
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a high-pressure liquid chromatography system designed for the analysis of tricyclic antidepressant drugs. It is classified as a Class II medical device under FDA regulation 862.3910 and is intended for clinical toxicology applications.

The device is supplied as a reusable system and requires proper storage conditions. It is not sterilized and is intended for single-use in analytical procedures. The device is authorized under FDA 510(k) clearance with decision code SESE.

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