Cleared Traditional

VALPROIC ACID

K936208 · Seradyn, Inc. · Chemistry
Mar 1994
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K936208 is an FDA 510(k) clearance for the VALPROIC ACID, a Enzyme Immunoassay, Valproic Acid (Class II — Special Controls, product code LEG), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 11, 1994, 72 days after receiving the submission on December 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K936208 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1993
Decision Date March 11, 1994
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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