Cleared Traditional

AXSYM TRICYCLIC ANTIDEPRESSANTS

K953761 · Abbott Laboratories · Toxicology
Nov 1995
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K953761 is an FDA 510(k) clearance for the AXSYM TRICYCLIC ANTIDEPRESSANTS, a U.v. Spectrometry, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFH), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 22, 1995, 103 days after receiving the submission on August 11, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K953761 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1995
Decision Date November 22, 1995
Days to Decision 103 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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