# Accelerate Diagnostics, Inc.

- Location (FDA's records): Tucson, AZ
- FDA decisions: 2 (2020–2024): 2 510(k) clearances
- Product codes: PRH (1), QNJ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Accelerate Diagnotics: 1 (https://510kreport.com/company/accelerate-diagnotics)
- Bruker Daltonik GmbH: 1 (https://510kreport.com/company/bruker-daltonik)

## Firms that cite its devices most
- Avails Medical, Inc.: 1 (https://510kreport.com/company/avails-medical)
- Affinity Biosensors, LLC: 1 (https://510kreport.com/company/affinity-biosensors)

## Its most-cited devices
- K192665: Accelerate Pheno System, Accelerate PhenoTest BC Kit (2020), cited by 2

## Recent decisions
- K240854: Accelerate Arc System (Sep 26, 2024)
- K192665: Accelerate Pheno System, Accelerate PhenoTest BC Kit (Sep 15, 2020)

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