# Olympus Diagnostica GmbH

- Location (FDA's records): Melville, NY
- FDA decisions: 4 (1998–2000): 4 510(k) clearances
- Product codes: CJY (1), JIT (1), DDR (1), CGS (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K994189: Olympus Creatine Kinase Reagent OSR6179/6279 (Jan 20, 2000)
- K984145: Olympus Myoglobin Immunoturbidmetric Reagent (Dec 23, 1998)
- K981854: Olympus Serum Protein Multicalibrator, (Aug 18, 1998)
- K982035: Olympus Calcium Arsenazo Iii Reagent (Jun 24, 1998)

Source page: https://510kreport.com/company/olympus-diagnostica