510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260770Substantially Equivalent

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

Diasorin Inc., Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260770 is the FDA 510(k) clearance record for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX, a class II device, cleared for DiaSorin, Inc. on under FDA product code LOM (Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)). FDA's definition for product code LOM reads: "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...". FDA records list 74 510(k) clearances for DiaSorin, Inc., from to . As of , FDA records show no recalls naming K260770.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation
21 CFR 866.3172
Device class
Class II
Review panel
Microbiology
Applicant
DiaSorin, Inc. 1951 Northwestern Ave., Stillwater MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LOM

Trailing 12 months
1 clearance under product code LOM in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LOM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260