Cleared Traditional

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20

K192515 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Toxicology
Oct 2019
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K192515 is an FDA 510(k) clearance for the BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 11, 2019, 28 days after receiving the submission on September 13, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K192515 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2019
Decision Date October 11, 2019
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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