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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K260770

510(k) cleared

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

DiaSorin, Inc. · Jun 4, 2026 · K260770

FDA cleared the LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX from DiaSorin, Inc. on Jun 4, 2026 under K260770, a traditional 510(k). The device falls under product code LOM, Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen), regulated at 21 CFR 866.3172 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Mar 9, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

DiaSorin, Inc. has 2 other decisions in the tracker over the last 12 months: P250039 (LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus), DEN250032 (LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)).

Questions & Answers

What did FDA clear under K260770?

K260770 is the FDA 510(k) for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX, submitted by DiaSorin, Inc.. FDA's decision date was Jun 4, 2026, under product code LOM (Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)).

Who makes the LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX?

DiaSorin, Inc., based in Stillwater, MN, is the applicant of record for K260770.

How long did the K260770 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Jun 4, 2026, 87 days later.

← All decisions in June 2026

Sources