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Redi-Screen

by Redwood Biotech, Inc. 2 variants

510(k) K000979

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK000979 Date10 Apr 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
LAF
Device Class
Class II
Regulation
21 CFR Part 862.3610
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

Redi-Screen is a gas chromatography device used for clinical toxicology testing. It is designed to detect specific analytes, including methamphetamine and cannabinoids, within the field of toxicology and therapeutic drug monitoring.

This device is classified as a Class 2 medical device and has received FDA 510(k) clearance. It is intended for use in clinical settings for the analysis of biological samples.

Other devices from Redwood Biotech, Inc.