Cleared Traditional

BioSieve? Marijuana Test Panel 50; BioSieve? Marijuana Test Strip 50; BioSieve? Dx Marijuana Test Strip 20; BioSieve? Dx Marijuana Test Strip 50; BioSieve? Dx Marijuana Test Panel 20; BioSieve? Dx Marijuana Test Panel 50

K231978 · Vivachek Biotech (Hangzhou) Co., Ltd. · Toxicology

Aug 2023

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K231978 is an FDA 510(k) clearance for the BioSieve? Marijuana Test Panel 50; BioSieve? Marijuana Test Strip 50; BioSieve? Dx Marijuana Test Strip 20; BioSieve? Dx Marijuana Test Strip 50; BioSieve? Dx Marijuana Test Panel 20; BioSieve? Dx Marijuana Test Panel 50, a Test, Cannabinoid, Over The Counter (Class II — Special Controls, product code NFW), submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 31, 2023, 59 days after receiving the submission on July 3, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number	K231978 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2023
Decision Date	August 31, 2023
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF