Data / Medical devices / United States / Bruker Scientific LLC
Bruker Scientific LLC: FDA-registered device maker in Billerica, MA, United States, 4 510(k) clearances
Bruker Scientific LLC is registered with the FDA (registration 3003961381) in Billerica, MA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003961381
- Address
- 40 Manning Rd, Billerica, MA, United States, 01821
- Owner or operator
- Bruker Scientific LLC (10044152)
- Roles
- Complaint file establishment
- First device listed
- December 12, 2013
- Registered through
- 2026
- Brand names listed
- BD Bruker MALDI Biotyper CA System, BD Bruker MBT-CA System, MALDI Biotyper CA System, MALDI Biotyper sirius CA System, MALDI Biotyper sirius one CA System, MALDI Biotyper-BD sirius CA System, MALDI Biotyper-BD sirius one CA System, MBT Biotarget 96 US IVD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mass Spectrometry, Microorganism Identification, Blood Culture | QNJ | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | PEX | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 27, 2020 | K193419 | MBT Sepsityper | QNJ | Substantially Equivalent | Bruker Daltonik GmbH | accessdata.fda.gov |
| July 26, 2017 | K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | PEX | Substantially Equivalent | Bruker Daltonik GmbH | accessdata.fda.gov |
| March 27, 2015 | K142677 | MALDI Biotyper CA System | PEX | Substantially Equivalent | Bruker Daltonics, Inc. | accessdata.fda.gov |
| November 21, 2013 | K130831 | MALDI BIOTYPER CA (MBT-CA) SYSTEM | PEX | Substantially Equivalent | Bruker Daltonics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mass Spectrometry, Microorganism Identification, Blood Culture
- All makers of System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Updated December 27, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.