The following data is part of a premarket notification filed by Bruker Daltonics, Inc with the FDA for Maldi Biotyper Ca (mbt-ca) System.
| Device ID | K130831 |
| 510k Number | K130831 |
| Device Name: | MALDI BIOTYPER CA (MBT-CA) SYSTEM |
| Classification | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant | BRUKER DALTONICS, INC 180 Cabot Street Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White BRUKER DALTONICS, INC 180 Cabot Street Beverly, MA 01915 |
| Product Code | PEX |
| CFR Regulation Number | 866.3361 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2013-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251204325734 | K130831 | 000 |
| 00841594100031 | K130831 | 000 |
| 00841594110030 | K130831 | 000 |
| 00841594110047 | K130831 | 000 |
| 10841594110020 | K130831 | 000 |
| 10841594110013 | K130831 | 000 |
| 10841594110099 | K130831 | 000 |
| 04251204300014 | K130831 | 000 |
| 04251204325642 | K130831 | 000 |
| 04251204325659 | K130831 | 000 |
| 04251204325666 | K130831 | 000 |
| 04251204325710 | K130831 | 000 |
| 00841594100024 | K130831 | 000 |