Cleared Traditional

BioSieve? Fentanyl FIA Home Test Kit; BioSieve? Fentanyl FIA Pro Test Kit; BioSieve? Toxismart Reader

K241869 · Vivachek Biotech (Hangzhou) Co., Ltd. · Toxicology
Oct 2024
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K241869 is an FDA 510(k) clearance for the BioSieve? Fentanyl FIA Home Test Kit; BioSieve? Fentanyl FIA Pro Test Kit; BioSieve? Toxismart Reader, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 4, 2024, 99 days after receiving the submission on June 27, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K241869 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2024
Decision Date October 04, 2024
Days to Decision 99 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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