The following data is part of a De Novo classification by Tandem Diabetes Care, Inc. with the FDA for Control-iq Technology.
| DeNovo ID | DEN190034 |
| Device Name: | Control-IQ Technology |
| Classification | Interoperable Automated Glycemic Controller |
| Applicant | Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 |
| Contact | Michael Sarrasin |
| Product Code | QJI |
| CFR Regulation Number | 862.1356 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Clinical Chemistry |
| Classification Advisory | Clinical Chemistry |
| Type | Direct |
| Date Received | 2019-07-15 |
| Decision Date | 2019-12-13 |
| Reclassification Order: | Reclassification Order |