# Cambridge Diagnostics Ireland, Ltd.

- Location (FDA's records): Galway, IE
- FDA decisions: 4 (1996–2001): 4 510(k) clearances
- Product codes: LCX (2), LSR (2)
- Predicates its devices cite: 1 (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
- Selfcare, Inc.: 1 (https://510kreport.com/company/selfcare)

## Recent decisions
- K013907: Inverness Medical Early Pregnancy Test (Dec 18, 2001)
- K970768: Human Lyme Igm Western Blot Kit (Apr 9, 1998)
- K970761: Limited Human Lyme Igg Western Blot Kit (Cambridge Diagnostics Ireland) (Apr 9, 1998)
- K955903: Selfcare Early Pregnancy Test (Mar 6, 1996)

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