Cleared Traditional

VALPROIC ACID EIA TEST

K961988 · Diagnostic Reagents, Inc. · Toxicology
Jul 1996
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K961988 is an FDA 510(k) clearance for the VALPROIC ACID EIA TEST, a Enzyme Immunoassay, Valproic Acid (Class II — Special Controls, product code LEG), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 16, 1996, 56 days after receiving the submission on May 21, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K961988 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1996
Decision Date July 16, 1996
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LEG — Enzyme Immunoassay, Valproic Acid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

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