Cleared Traditional

QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075

K030405 · Seradyn · Toxicology

Apr 2003

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K030405 is an FDA 510(k) clearance for the QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075, a Enzyme Immunoassay, Valproic Acid (Class II — Special Controls, product code LEG), submitted by Seradyn (Indianapolis, US). The FDA issued a Cleared decision on April 28, 2003, 81 days after receiving the submission on February 6, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number	K030405 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2003
Decision Date	April 28, 2003
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF