510(k) K142677
K142677 is an FDA 510(k) premarket notification submitted by Bruker Daltonics, Inc. for the device "MALDI Biotyper CA System". The FDA issued a decision of Substantially Equivalent on March 27, 2015. 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 Daltonics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2015
- Date Received
- September 19, 2014
- 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.