510(k) K260770
K260770 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX". The FDA issued a decision of Substantially Equivalent on June 4, 2026. The device falls under product code LOM (Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)), a Class II device regulated under 21 CFR 866.3172. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2026
- Date Received
- March 9, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Device Class
- Class II
- Regulation Number
- 866.3172
- Review Panel
- MI
- Submission Type
In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.