# Beckman Coulter Ireland, Inc.

- Location (FDA's records): Co. Clare, IE
- FDA decisions: 7 (2013–2019): 7 510(k) clearances
- Product codes: JZG (1), JIX (1), JIT (1), KHS (1), PDJ (1), DDB (1), DCF (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus America, Inc.: 2 (https://510kreport.com/company/olympus-america)
- Beckman Instruments, Inc.: 2 (https://510kreport.com/company/beckman-instruments)
- Beckman Coulter, Inc.: 2 (https://510kreport.com/company/beckman-coulter)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)

## Recent decisions
- K182651: HbA1c Advanced (Jan 16, 2019)
- K161508: Ceruloplasmin (Jan 9, 2017)
- K161297: Beta-2-Microglobulin (Jun 7, 2016)
- K142346: Urine/CSF Albumin, Urine/CSF Albumin Calibrator (Oct 15, 2014)
- K141388: System Calibrater (Jul 11, 2014)
- K141374: Bicarbonate Calibrator (Jun 30, 2014)
- K131546: AU Bicarbonate Reagent (Oct 9, 2013)

Source page: https://510kreport.com/company/beckman-coulter-ireland