510(k) K181475
K181475 is an FDA 510(k) premarket notification submitted by Beckman Coulter for the device "DxH 520 Hematology Instrument". The FDA issued a decision of Substantially Equivalent - With Limitations on Mar 1, 2019. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Beckman Coulter has 277 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU (Substantially Equivalent - With Limitations)
- Decision Date
- Mar 1, 2019
- Date Received
- Jun 4, 2018
- 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
- 510(k)