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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 / K260333

510(k) cleared

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit

Diasorin Molecular, LLC · Jun 15, 2026 · K260333

FDA cleared the LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit from Diasorin Molecular, LLC on Jun 15, 2026 under K260333, a dual track 510(k). The device falls under product code PGX, Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System, regulated at 21 CFR 866.2680 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Feb 2, 2026. The decision came 133 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: K251978 (LIAISON NES FLU A/B, RSV & COVID-19), 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 K260333?

K260333 is the FDA 510(k) for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit, submitted by Diasorin Molecular, LLC. FDA's decision date was Jun 15, 2026, under product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System).

Who makes the LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

Diasorin Molecular, LLC, based in Cypress, CA, is the applicant of record for K260333.

How long did the K260333 review take?

FDA received the submission on Feb 2, 2026 and issued its decision on Jun 15, 2026, 133 days later.

← All decisions in June 2026

Sources