The following data is part of a De Novo classification by Bruker Daltonik Gmbh with the FDA for Maldi Biotyper Ca System.
| DeNovo ID | DEN170081 |
| Device Name: | MALDI Biotyper CA System |
| Classification | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant | Bruker Daltonik GmbH fahrenheitstrasse 4 Bremen, DE 28359 |
| Contact | Markus Kostrzewa |
| Product Code | QBN |
| CFR Regulation Number | 866.3378 [🔎] |
| 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 | 2017-09-29 |
| Decision Date | 2018-04-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |