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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 the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) 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. The listed applicant is Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. The 510(k) number is K231027.

When did KaiBiLi Extended ViralTrans receive FDA 510(k) clearance?

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

Who is the listed applicant for KaiBiLi Extended ViralTrans?

The FDA 510(k) record lists Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KaiBiLi Extended ViralTrans?

The FDA product code for KaiBiLi Extended ViralTrans is JSM.

Related Devices (Code: JSM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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