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FDA 510(k)

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

K-Number: K260770 · 2026-06-04

Decision Date2026-06-04
Product CodeLOM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K260770. The device is classified under product code LOM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX?

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is DiaSorin, Inc.. The 510(k) number is K260770.

When did LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX receive FDA 510(k) clearance?

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX received FDA 510(k) clearance on 2026-06-04, under 510(k) number K260770.

Who is the listed applicant for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX?

The FDA product code for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX is LOM.

Other records listing DiaSorin, Inc. as applicant

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.

View all 43 devices →

Related Devices (Code: LOM)

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.

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.