Cleared Traditional

BIOEASY Multi-Drug Test Cup

K193480 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Toxicology
Jan 2020
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K193480 is an FDA 510(k) clearance for the BIOEASY Multi-Drug Test Cup, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 31, 2020, 46 days after receiving the submission on December 16, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K193480 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2019
Decision Date January 31, 2020
Days to Decision 46 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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