K163536 is an FDA 510(k) clearance for the MALDI Biotyper CA (MBT-CA) System, MBT smart CA System. This device is classified as a System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (Class II - Special Controls, product code PEX).
Submitted by Bruker Daltonik GmbH (Bremen, DE). The FDA issued a Cleared decision on July 26, 2017, 222 days after receiving the submission on December 16, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3361. A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ Ionization - Time Of Flight (maldi-tof) For The Identification Of Microorganisms Cultured From Human Specimens..
| 510(k) Number | K163536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2016 |
| Decision Date | July 26, 2017 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PEX - System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3361 |
| Definition | A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ Ionization - Time Of Flight (maldi-tof) For The Identification Of Microorganisms Cultured From Human Specimens. |