# Olympus Life & Material Science Europa GmbH (Irish

- Location (FDA's records): Co. Clare, IE
- FDA decisions: 3 (2007–2007): 3 510(k) clearances
- Product codes: CEC (1), GHH (1), JHY (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (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
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)

## Recent decisions
- K070708: Olympus FT4-Free Thyroxine,  Olympus T4- Total Thyroxine, Model# OSR210102, OSR210104 (Aug 21, 2007)
- K070453: Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control (Jun 11, 2007)
- K070835: Olympus CK-MB Reagent (Jun 4, 2007)

Source page: https://510kreport.com/company/olympus-life-material-science-europa-irish