510(k) K240252
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System by
Beckman Coulter, Inc.
— Product Code GKZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 5, 2024
- Date Received
- January 30, 2024
- 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