Cleared Traditional

MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY

K983268 · Diagnostic Reagents, Inc. · Toxicology
Nov 1998
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K983268 is an FDA 510(k) clearance for the MODIFICATION OF TRICYCLIC SERUM TOX EIA 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 November 18, 1998, 62 days after receiving the submission on September 17, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K983268 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 1998
Decision Date November 18, 1998
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