Cleared Traditional

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

K192301 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Toxicology
Sep 2019
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K192301 is an FDA 510(k) clearance for the BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip, a Test, Cannabinoid, Over The Counter (Class II — Special Controls, product code NFW), submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 20, 2019, 28 days after receiving the submission on August 23, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K192301 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2019
Decision Date September 20, 2019
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NFW — Test, Cannabinoid, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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