# Ai DE Diagnostic Co., Ltd.

- Location (FDA's records): Iowa City, IA
- FDA decisions: 1 (2007–2007): 1 510(k) clearance
- Product codes: LCX (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
- K062703: One Step HCG Pregnancy Test (Jul 23, 2007)

Source page: https://510kreport.com/company/ai-de-diagnostic