The following data is part of a premarket notification filed by Bruker Daltonik Gmbh with the FDA for Maldi Biotyper Ca (mbt-ca) System, Mbt Smart Ca System.
| Device ID | K163536 |
| 510k Number | K163536 |
| Device Name: | MALDI Biotyper CA (MBT-CA) System, MBT Smart CA System |
| Classification | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant | BRUKER DALTONIK GMBH FAHRENHEITSTRASSE 4 Bremen, DE 28359 |
| Contact | Markus Kostrzewa |
| Correspondent | David Cromwick BRUKER DALTONICS, INC 40 MANNING ROAD Billerica, MA 01821 |
| Product Code | PEX |
| CFR Regulation Number | 866.3361 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251204325772 | K163536 | 000 |
| 04251204326168 | K163536 | 000 |
| 04251204326359 | K163536 | 000 |
| 04251204326311 | K163536 | 000 |
| 04251204326175 | K163536 | 000 |