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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 / December 2025 / K251978

510(k) cleared

LIAISON NES FLU A/B, RSV & COVID-19

Diasorin Molecular, LLC · Dec 23, 2025 · K251978

FDA cleared the LIAISON NES FLU A/B, RSV & COVID-19 from Diasorin Molecular, LLC on Dec 23, 2025 under K251978, a dual track 510(k). The device falls under product code QOF, Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, regulated at 21 CFR 866.3981 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 27, 2025. The decision came 179 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Diasorin Molecular, LLC has 2 other decisions in the tracker over the last 12 months: K260333 (LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit), K252387 (Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)).

Questions & Answers

What did FDA clear under K251978?

K251978 is the FDA 510(k) for LIAISON NES FLU A/B, RSV & COVID-19, submitted by Diasorin Molecular, LLC. FDA's decision date was Dec 23, 2025, under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents).

Who makes the LIAISON NES FLU A/B, RSV & COVID-19?

Diasorin Molecular, LLC, based in Cypress, CA, is the applicant of record for K251978.

How long did the K251978 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Dec 23, 2025, 179 days later.

← All decisions in December 2025

Sources