MALDI BIOTYPER CA (MBT-CA) SYSTEM is an AI-enabled medical device from BRUKER DALTONICS, INC, listed by FDA (510(k), K130831) with a decision date of 2013-11-21. Review panel: Microbiology.
| FDA submission number | K130831 |
|---|---|
| Pathway | 510(k) |
| Company | BRUKER DALTONICS, INC |
| Review panel (specialty) | Microbiology |
| FDA decision date | 2013-11-21 |
| Decision | Substantially Equivalent |
| Product code | PEX |
| Classification | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Device class | 2 |
| Regulation number | 866.3361 |
| Review time (calendar days) | 240 |
| Applicant country | US |
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.