Cleared Traditional

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

K250803 · Anhui Deepblue Medical Technological Co., Ltd. · Toxicology
Apr 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K250803 is an FDA 510(k) clearance for the Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Anhui Deepblue Medical Technological Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on April 15, 2025, 29 days after receiving the submission on March 17, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K250803 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2025
Decision Date April 15, 2025
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NGL — Test, Opiates, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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