Cleared Traditional

TRICYCLICS SERUM TOX ASSAY

K961393 · Diagnostic Reagents, Inc. · Toxicology
Jun 1996
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K961393 is an FDA 510(k) clearance for the TRICYCLICS SERUM TOX ASSAY, a U.v. Spectrometry, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFH), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 12, 1996, 62 days after receiving the submission on April 11, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K961393 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1996
Decision Date June 12, 1996
Days to Decision 62 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

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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