# Abx Diagnostics

- Location (FDA's records): Irvine, CA
- FDA decisions: 10 (1999–2003): 10 510(k) clearances
- Product codes: GKZ (9), GKX (1)
- Predicates its devices cite: 17 (8 its own); citations of its devices by later devices: 17 (8 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abx, Inc.: 3 (https://510kreport.com/company/abx)
- Abbott Diagnostics: 2 (https://510kreport.com/company/abbott-diagnostics)
- Coulter Corp.: 1 (https://510kreport.com/company/coulter)
- Serono Diagnostics, Inc.: 1 (https://510kreport.com/company/serono-diagnostics)
- Toa Medical Electronics USA, Inc.: 1 (https://510kreport.com/company/toa-medical-electronics-usa)
- Sysmex Corp.: 1 (https://510kreport.com/company/sysmex)

## Firms that cite its devices most
- Horiba Abx: 8 (https://510kreport.com/company/horiba-abx)
- Horiba, Ltd.: 1 (https://510kreport.com/company/horiba)

## Its most-cited devices
- K990311: Vega Retic Automated Hematology Analyzer (1999), cited by 4
- K991839: Abx Pentra 120 Retic Automated Hematology Analyzer (1999), cited by 3
- K992511: Abx Pentra 60   Hematology Analyzer (1999), cited by 2
- K003677: Abx Pentra 60C+ Hematology Analyzer (2000), cited by 2
- K002646: Abx Micros CRP (2000), cited by 2
- K024002: Pentra 80 (2003), cited by 1

## Recent decisions
- K030799: Micros 60 (Apr 8, 2003)
- K030144: Modification to Pentra 60 and Pentra 60C+ (Jan 31, 2003)
- K024002: Pentra 80 (Jan 3, 2003)
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 (Jul 29, 2002)
- K014203: Abx Micros 60 Hematology Analyzer (Feb 28, 2002)
- K003677: Abx Pentra 60C+ Hematology Analyzer (Dec 26, 2000)
- K002646: Abx Micros CRP (Oct 26, 2000)
- K992511: Abx Pentra 60   Hematology Analyzer (Oct 15, 1999)

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