# Orgentec Diagnostika GmbH

- Location (FDA's records): East Stroudsburg, PA
- FDA decisions: 3 (2003–2010): 3 510(k) clearances
- Product codes: LJM (1), OQZ (1), DHR (1)
- 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
- Eurodiagnostica: 1 (https://510kreport.com/company/eurodiagnostica)

## Recent decisions
- K100499: Orgentec Rheumatoid Factor Eia (Oct 27, 2010)
- K092399: Anti-Mutated Citrullinated Vimentin Eia (Jul 1, 2010)
- K030929: Ana Detect (May 2, 2003)

Source page: https://510kreport.com/company/orgentec-diagnostika