510(k) K240854
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2024
- Date Received
- March 28, 2024
- 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.