Cleared Traditional

K260355 - Webest Multi-Drug Urine Cup (FDA 510(k) Clearance)

Also includes:
Webest Home Multi-Drug Urine Cup
Mar 2026
Decision
34d
Days
Class 2
Risk

K260355 is an FDA 510(k) clearance for the Webest Multi-Drug Urine Cup. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K260355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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

Device Classification

Product Code NFT — Test, Amphetamine, Over The Counter
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.3100