KaiBiLi Extended ViralTrans— 510(k) K231027

Name: FDA 510(k) clearance K231027
Creator: U.S. Food and Drug Administration
Published: 2023-12-21

Substantially Equivalent

Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.

FDA 510(k) clearance K231027 for KaiBiLi Extended ViralTrans, Substantially Equivalent on 2023-12-21. Applicant: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2023-04-11
Decision date: 2023-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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