# Gentian AS

- Location (FDA's records): San Diego, CA
- FDA decisions: 2 (2007–2008): 2 510(k) clearances
- Product codes: NDY (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 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
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)

## Its most-cited devices
- K071388: Gentian Cystatin C Immunoassay (2007), cited by 1

## Recent decisions
- K081875: Gentian Cystatin C Immunoassay (Aug 20, 2008)
- K071388: Gentian Cystatin C Immunoassay (Nov 6, 2007)

Source page: https://510kreport.com/company/gentian