Skip to content

Escreen System

by Escreen, Inc.

510(k) K003352

Escreen System is a medical device (FDA Class II; FDA product code LAF, Gas Chromatography, Methamphetamine) made by Escreen, Inc., cleared under FDA 510(k) K003352 on 20 Mar 2001, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003352 Date20 Mar 2001ClearedStatusActive

Official records

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  • Withdrawn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
LAF
Device class
Class II
Regulation
21 CFR Part 862.3610
Advisory committee
Clinical Toxicology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code LAF (Gas Chromatography, Methamphetamine).

Other devices from Escreen, Inc.

See all devices from Escreen, Inc. →