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

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K260770 for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX, Substantially Equivalent on 2026-06-04. Applicant: DiaSorin, Inc..

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code LOM
Advisory panel: Microbiology
Date received: 2026-03-09
Decision date: 2026-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOM

product code LOM

Malfunction: 1,251
Total: 1,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.