# Euro-Diagnostica AB

- Location (FDA's records): Ringoes, NJ
- FDA decisions: 6 (1997–2010): 6 510(k) clearances
- Product codes: NHX (3), MOB (2), DBL (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Eurodiagnostica: 2 (https://510kreport.com/company/eurodiagnostica)

## Recent decisions
- K093908: Ccpoint (Dec 1, 2010)
- K091657: Immunoscan Ccplus (Nov 19, 2009)
- K062045: Edia Anti-CCP (Dec 4, 2006)
- K971464: Immunoscan Anti-GBM Quantitative Kit (Oct 29, 1997)
- K971690: Immunoscan PR3-Anca (Oct 29, 1997)
- K971689: Immunoscan Anti-Myeloperoxidase Antibodies (Mpo-Anca) Quantitative Kit (Oct 29, 1997)

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