# Genabio Diagnostics, Inc.

- Location (FDA's records): Bedford, MA
- FDA decisions: 2 (2024–2025): 2 510(k) clearances
- Product codes: LZA (1), QYT (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Comfort Rubber Gloves Industries Sdn. Bhd.: 1 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Firms that cite its devices most
- Sunray Medical Products, Inc.: 1 (https://510kreport.com/company/sunray-medical-products)

## Its most-cited devices
- K240545: GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) (2024), cited by 1

## Recent decisions
- K251753: GenaCheck COVID-19 Rapid Self-Test (Sep 5, 2025)
- K240545: GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) (Aug 28, 2024)

Source page: https://510kreport.com/company/genabio-diagnostics