Genabio Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Genabio Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: GenaCheck COVID-19 Rapid Self-Test, GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
2
Total
2
Cleared
0
Denied
Genabio Diagnostics, Inc. has 2 FDA 510(k) cleared medical devices. Based in Bedford, US.
Latest FDA clearance: Sep 2025. Active since 2024. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Genabio Diagnostics, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Genabio Diagnostics, Inc.
2 devices