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FDA 510(k)

KaiBiLi Extended ViralTrans

K-Number: K231027 · 2023-12-21

ApplicantHangzhou Genesis Biodetection & Biocontrol Co., Ltd.
Decision Date2023-12-21
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

KaiBiLi Extended ViralTrans is a medical device manufactured by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under approval number K231027. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KaiBiLi Extended ViralTrans?

KaiBiLi Extended ViralTrans is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. The 510(k) number is K231027.

When was KaiBiLi Extended ViralTrans approved by the FDA?

KaiBiLi Extended ViralTrans received FDA 510(k) clearance on 2023-12-21, under approval number K231027.

What company makes KaiBiLi Extended ViralTrans?

KaiBiLi Extended ViralTrans is manufactured by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd..

What is the FDA product code for KaiBiLi Extended ViralTrans?

The FDA product code for KaiBiLi Extended ViralTrans is JSM.

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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.

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