FDA 510(k)

BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader

K-Number: K240124 · 2024-06-14

ApplicantVivachek Biotech (Hangzhou) Co., Ltd.

Decision Date2024-06-14

Product CodeDJG

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader is a medical device manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-14 under approval number K240124. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader?

BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K240124.

When was BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader approved by the FDA?

BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader received FDA 510(k) clearance on 2024-06-14, under approval number K240124.

What company makes BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader?

BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd..

What is the FDA product code for BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader?

The FDA product code for BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader is DJG.

Other Devices by Vivachek Biotech (Hangzhou) Co., Ltd.

K192957VivaChek Blood Glucose and B-Ketone Monitoring System K222667Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx K233058VivaChek Link Plus Blood Glucose Monitoring System K233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx K231978BioSieve 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 K241869BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader

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Related Devices (Code: DJG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.