Name: Predicase
Price: 199 USD

K-number	K240124
Device name	BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
Applicant	Vivachek Biotech (Hangzhou) Co., Ltd.
Product code	DJG
Device class	Class II
Decision date	Jun 14, 2024
Decision	Substantially Equivalent
Regulation	862.3650

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader

Everything you need for a 510(k) submission. Nothing you don't.

BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader