The following data is part of a premarket notification filed by Bruker Daltonics, Inc with the FDA for Maldi Biotyper Ca System.
| Device ID | K142677 |
| 510k Number | K142677 |
| Device Name: | MALDI Biotyper CA System |
| Classification | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant | BRUKER DALTONICS, INC 40 MANNING RD Billerica, MA 01821 |
| Contact | Ken Hirakawa |
| Correspondent | Markus Kostrzewa BRUKER DALTONICS, INC Fahrenheilstrasse-4 Bremen, DE 28359 |
| Product Code | PEX |
| CFR Regulation Number | 866.3361 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-19 |
| Decision Date | 2015-03-27 |
| Summary: | summary |