The following data is part of a premarket notification filed by Bruker Daltonik Gmbh with the FDA for Mbt Sepsityper.
| Device ID | K193419 |
| 510k Number | K193419 |
| Device Name: | MBT Sepsityper |
| Classification | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant | Bruker Daltonik GmbH Fahrenheitstrasse 4 Bremen, DE 28359 |
| Contact | Peter Trinder |
| Correspondent | Peter Trinder Bruker Daltonik GmbH Fahrenheitstrasse 4 Bremen, DE 28359 |
| Product Code | PEX |
| CFR Regulation Number | 866.3361 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-09 |
| Decision Date | 2020-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251204326304 | K193419 | 000 |
| 04251204326298 | K193419 | 000 |
| 04251204326182 | K193419 | 000 |