Skip to content

Phenytoin Kit Fluorescence Polarization

by Windsor Laboratories, Inc. 510(k)

Active United States

510(k) K842586

Overview

This device is a fluorescence polarization immunoassay for the quantitative determination of diphenylhydantoin (total) in human serum or plasma. It is classified as a Class II medical device under regulation number 862.3350 and falls within the clinical toxicology specialty.

The Phenytoin Kit Fluorescence Polarization (K842586) received traditional 510(k) clearance from the FDA on September 26, 1984, following submission on July 3, 1984. It is manufactured by Windsor Laboratories, Inc. in McHenry, Illinois, and is identified by product code LGR.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842586 Date26 Sep 1984ClearedStatusActive

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
LGR
Device Class
Class II
Regulation
21 CFR Part 862.3350
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Other devices from Windsor Laboratories, Inc.

See all devices from Windsor Laboratories, Inc. →

Questions

  • What is the Phenytoin Kit Fluorescence Polarization used for?

    It is used for the quantitative determination of diphenylhydantoin (total) in human serum or plasma, enabling clinicians to monitor phenytoin levels for therapeutic drug management.

  • How is the Phenytoin Kit Fluorescence Polarization supplied and what is its intended use setting?

    The kit is supplied as a fluorescence polarization immunoassay reagent system intended for in vitro diagnostic use in clinical laboratories to measure phenytoin concentrations in blood samples.

  • What regulatory pathway was used for the Phenytoin Kit Fluorescence Polarization and what is its classification?

    It received traditional 510(k) clearance (K842586) from the FDA and is classified as a Class II medical device under regulation 862.3350 in the clinical toxicology specialty.