510(k) K141810
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2014
- Date Received
- July 7, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Blood Culturing
- Device Class
- Class I
- Regulation Number
- 866.2560
- Review Panel
- MI
- Submission Type