510(k) K193419
K193419 is an FDA 510(k) premarket notification submitted by Bruker Daltonik GmbH for the device "MBT Sepsityper". The FDA issued a decision of Substantially Equivalent on December 27, 2020. The device falls under product code QNJ (Mass Spectrometry, Microorganism Identification, Blood Culture), a Class II device regulated under 21 CFR 866.3378. Bruker Daltonik GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2020
- Date Received
- December 9, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mass Spectrometry, Microorganism Identification, Blood Culture
- Device Class
- Class II
- Regulation Number
- 866.3378
- Review Panel
- MI
- Submission Type
Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.