510(k) K163536
K163536 is an FDA 510(k) premarket notification submitted by Bruker Daltonik GmbH for the device "MALDI Biotyper CA (MBT-CA) System, MBT smart CA System". The FDA issued a decision of Substantially Equivalent on July 26, 2017. The device falls under product code PEX (System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates), a Class II device regulated under 21 CFR 866.3361. Bruker Daltonik GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2017
- Date Received
- December 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- Device Class
- Class II
- Regulation Number
- 866.3361
- Review Panel
- MI
- Submission Type
A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.