Panels › Microbiology › Product code QBN · Class 2
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Regulation 866.3378
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QBN
| Company | 510(k)s | Recalls |
|---|---|---|
| bioMerieux, Inc. | 2 | 0 |
| Bruker Daltonics GmbH & Co. KG | 1 | 0 |
| Bruker Daltonik GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2025 | K251495 | MBT Compass HT CA Software; MBT FAST Shuttle US IVD Bruker Daltonics GmbH & Co. KG, DE | QBN |
| Mar 15, 2022 | K212461 | VITEK MS PRIME bioMerieux, Inc. | QBN |
| Dec 21, 2018 | K181412 | VITEK MS bioMerieux, Inc. | QBN |
| Apr 20, 2018 | DEN170081 | MALDI Biotyper CA System Bruker Daltonik GmbH, DE | QBN |
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