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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 / May 2026 / K253722

510(k) cleared

LIAISON PLEX Gastrointestinal Flex Assay

Luminex Corporation · May 19, 2026 · K253722

FDA cleared the LIAISON PLEX Gastrointestinal Flex Assay from Luminex Corporation on May 19, 2026 under K253722, a traditional 510(k). The device falls under product code PCH, Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, regulated at 21 CFR 866.3990 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Nov 24, 2025. The decision came 176 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Luminex Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253722?

K253722 is the FDA 510(k) for LIAISON PLEX Gastrointestinal Flex Assay, submitted by Luminex Corporation. FDA's decision date was May 19, 2026, under product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System).

Who makes the LIAISON PLEX Gastrointestinal Flex Assay?

Luminex Corporation, based in Northbrook, IL, is the applicant of record for K253722.

How long did the K253722 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on May 19, 2026, 176 days later.

← All decisions in May 2026