510(k) K020496
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY by
Sysmex Corporation of America
— Product Code GKZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2002
- Date Received
- February 14, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type