# Columbia Diagnostics, Inc.

- Location (FDA's records): Springfield, VA
- FDA decisions: 2 (1985–1994): 2 510(k) clearances
- Product codes: JJY (1), DKC (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
- K935819: Quality Control Material (Assayed) (Mar 22, 1994)
- K854119: Accuracy (Oct 25, 1985)

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