Cleared Traditional

Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup

K260355 · WEBEST Biotech,, LLC · Toxicology

Mar 2026

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K260355 is an FDA 510(k) clearance for the Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by WEBEST Biotech,, LLC (Irwindale, US). The FDA issued a Cleared decision on March 9, 2026, 34 days after receiving the submission on February 3, 2026. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K260355 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2026
Decision Date	March 09, 2026
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF