Cleared Special

EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL

K011947 · Syva Co. · Toxicology
Jul 2001
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K011947 is an FDA 510(k) clearance for the EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL, a Enzyme Immunoassay, Valproic Acid (Class II — Special Controls, product code LEG), submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on July 2, 2001, 11 days after receiving the submission on June 21, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K011947 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2001
Decision Date July 02, 2001
Days to Decision 11 days
Submission Type Special
Review Panel Toxicology (TX)
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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