| DeNovo ID | DEN160032 |
| Device Name: | Accelerate Pheno System, Accelerate Phenotest BC Kit |
| Classification | 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 Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Device Classification Under Section 513(f)(2)(de Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd |
| Applicant | ACCELERATE DIAGNOTICS 3950 S. Country Club Road #470 Tucson, AZ 85714 |
| Contact | Maureen Mende |
| Product Code | PRH |
| CFR Regulation Number | Device Classification Under Section 513(f)(2)(de N [🔎] |
| 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 | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2016-07-11 |
| Decision Date | 2017-02-23 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |