# Sqi Diagnostics Systems

- Location (FDA's records): Toronto, On, CA
- FDA decisions: 3 (2009–2014): 3 510(k) clearances
- Names in FDA's records: Sqi Diagnostics Systems (2); Sqi Diagnostics Systems, Inc. (1)
- Product codes: MVM (2), DHR (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 1 (1 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
- Inova Diagnostics, Inc.: 7 (https://510kreport.com/company/inova-diagnostics)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)
- Aesku, Inc.: 1 (https://510kreport.com/company/aesku)

## Its most-cited devices
- K102490: Igx Plex Celiac Qualitative Assay (2011), cited by 1

## Recent decisions
- K140691: IG_Plex Celiac DGP Panel (Nov 6, 2014)
- K102490: Igx Plex Celiac Qualitative Assay (Jun 2, 2011)
- K083080: Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform (Oct 29, 2009)

Source page: https://510kreport.com/company/sqi-diagnostics-systems