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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 / K253367

510(k) cleared

EliA CTD 13 Screen

Phadia AB · Jun 25, 2026 · K253367

FDA cleared the EliA CTD 13 Screen from Phadia AB on Jun 25, 2026 under K253367, a traditional 510(k). The device falls under product code LLL, Extractable Antinuclear Antibody, Antigen And Control, regulated at 21 CFR 866.5100 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Sep 30, 2025. The decision came 268 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 Phadia AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253367?

K253367 is the FDA 510(k) for EliA CTD 13 Screen, submitted by Phadia AB. FDA's decision date was Jun 25, 2026, under product code LLL (Extractable Antinuclear Antibody, Antigen And Control).

Who makes the EliA CTD 13 Screen?

Phadia AB, based in Uppsala, is the applicant of record for K253367.

How long did the K253367 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jun 25, 2026, 268 days later.

← All decisions in June 2026