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Legionella Immunofluorescent Antibody Test Kit

by Genetic Systems Corp.

510(k) K852237

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852237 Date22 Aug 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LHL
Device Class
Class II
Regulation
21 CFR Part 866.3300
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Legionella Immunofluorescent Antibody Test Kit is a reagent-based diagnostic device classified under Reagents, Antibody, Legionella, Direct & Indirect Fluorescent. It is designed for the detection of Legionella antibodies using immunofluorescence methodology.

This test kit is supplied as an in vitro diagnostic reagent for use in microbiology laboratories. It received FDA 510(k) clearance (K852237) on August 22, 1985, and is classified as a Class II device under regulation number 866.3300 with product code LHL.

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