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Valproic Acid

by Seradyn, Inc. 510(k)

Active United States

510(k) K936208

Overview

Valproic Acid is an Enzyme Immunoassay device used for the quantitation of valproic acid in human serum. It is designed to measure the concentration of valproic acid and its minor active metabolites, including 2-ethyl-2-phenylmalonamide, 2-N-propylglutaric acid and 2-N-propyl-4-pentenoic acid. The device is manufactured by Seradyn, Inc. and is part of the QMS™/MULTIGENT™ product line.

The Valproic Acid device is supplied as a single-use assay and is intended for in vitro diagnostic use. It is regulated under FDA 510(k) clearance with product code LEG and device class 2. The device received FDA clearance on March 11, 1994, with K number K936208. It is not indicated for MRI safety and should be stored according to the manufacturer's instructions.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK936208 Date11 Mar 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LEG
Device Class
Class II
Regulation
21 CFR Part 862.3645
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Valproic Acid device used for?

    The Valproic Acid device is an Enzyme Immunoassay used for the quantitation of valproic acid and its minor active metabolites in human serum, designed for in vitro diagnostic purposes.

  • How is the Valproic Acid device supplied?

    The device is supplied as a single-use assay and is part of the QMS™/MULTIGENT™ product line manufactured by Seradyn, Inc.

  • What is the regulatory status of the Valproic Acid device?

    The device is regulated under FDA 510(k) clearance with product code LEG and device class 2, receiving clearance on March 11, 1994, with K number K936208.

  • What metabolites does the Valproic Acid device measure?

    The device measures the concentration of valproic acid and its minor active metabolites, including 2-ethyl-2-phenylmalonamide, 2-N-propylglutaric acid and 2-N-propyl-4-pentenoic acid.