Source document or public record

FDA 510(k) K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

FDA 510(k) index record K260770. Device: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX. Applicant as listed: DiaSorin, Inc.. Decision date: 2026-06-04.

OtherU.S. Food and Drug Administration (FDA)2026-06-04

Source

"device_name": "LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K260770.

Device name: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX. Applicant as listed: DiaSorin, Inc..

Decision date: 2026-06-04. Decision wording: Substantially Equivalent.

Product code: LOM. Regulation: 21 CFR 866.3172. 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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