510(k) K100684
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2010
- Date Received
- March 10, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Automated Blood Cell Diluting
- Device Class
- Class I
- Regulation Number
- 864.5240
- Review Panel
- HE
- Submission Type