The following data is part of a De Novo classification by Banyan Biomarkers, Inc. with the FDA for Banyan Bti.
| DeNovo ID | DEN170045 |
| Device Name: | Banyan BTI |
| Classification | Brain Trauma Assessment Test |
| Applicant | Banyan Biomarkers, Inc. 16470 West Bernardo Drive suite 100 San Diego, CA 92127 |
| Contact | Steven P. Richieri |
| Product Code | QAT |
| CFR Regulation Number | 866.5830 [🔎] |
| 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 | Immunology |
| Classification Advisory | Immunology |
| Type | Direct |
| Date Received | 2017-08-28 |
| Decision Date | 2018-02-14 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |