Source document or public record
FDA 510(k) K231027 — KaiBiLi Extended ViralTrans
FDA 510(k) index record K231027. Device: KaiBiLi Extended ViralTrans. Applicant as listed: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. Decision date: 2023-12-21.
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"device_name": "KaiBiLi Extended ViralTrans"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K231027.
Device name: KaiBiLi Extended ViralTrans. Applicant as listed: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd..
Decision date: 2023-12-21. Decision wording: Substantially Equivalent.
Product code: JSM. Regulation: 21 CFR 866.2390. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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