# Sienna Biotech, Inc.

- Location (FDA's records): Columbia, MD
- FDA decisions: 3 (1996–1997): 3 510(k) clearances
- Product codes: LQN (2), LJO (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
- K970931: Copalis Torc Total Antibody Assay (Apr 24, 1997)
- K961784: Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/CMV Total Antibody Assays (Oct 31, 1996)
- K955799: Copalis CMV Total Antibody Assay (Jul 10, 1996)

Source page: https://510kreport.com/company/sienna-biotech