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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 / March 2026 / K251916

510(k) cleared

GenBody COVID-19 Ag Home Test

Genbody.Inc. · Mar 13, 2026 · K251916

FDA cleared the GenBody COVID-19 Ag Home Test from Genbody.Inc. on Mar 13, 2026 under K251916, a traditional 510(k). The device falls under product code QYT, Over-The-Counter Covid-19 Antigen Test, regulated at 21 CFR 866.3984 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 23, 2025. The decision came 263 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 Genbody.Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251916?

K251916 is the FDA 510(k) for GenBody COVID-19 Ag Home Test, submitted by Genbody.Inc.. FDA's decision date was Mar 13, 2026, under product code QYT (Over-The-Counter Covid-19 Antigen Test).

Who makes the GenBody COVID-19 Ag Home Test?

Genbody.Inc., based in Cheonan-Si, is the applicant of record for K251916.

How long did the K251916 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Mar 13, 2026, 263 days later.

← All decisions in March 2026