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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 / September 2025 / K251753

510(k) cleared

GenaCheck COVID-19 Rapid Self-Test

Genabio Diagnostics, Inc. · Sep 5, 2025 · K251753

FDA cleared the GenaCheck COVID-19 Rapid Self-Test from Genabio Diagnostics, Inc. on Sep 5, 2025 under K251753, 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 9, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Genabio Diagnostics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251753?

K251753 is the FDA 510(k) for GenaCheck COVID-19 Rapid Self-Test, submitted by Genabio Diagnostics, Inc.. FDA's decision date was Sep 5, 2025, under product code QYT (Over-The-Counter Covid-19 Antigen Test).

Who makes the GenaCheck COVID-19 Rapid Self-Test?

Genabio Diagnostics, Inc., based in Bedford, MA, is the applicant of record for K251753.

How long did the K251753 review take?

FDA received the submission on Jun 9, 2025 and issued its decision on Sep 5, 2025, 88 days later.

← All decisions in September 2025