Class Class II

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (K241869)

K241869 2024-10-04 Traditional
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Description

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader by Vivachek Biotech (Hangzhou) Co., Ltd. — FDA 510(k) cleared clinical toxicology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241869
Clearance Date2024-10-04
Clearance TypeTraditional
Product CodeNGL
Regulation Number862.3650

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