510(k) K143577
K143577 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "XW-100 Automated Hematology Analyzer, XW QC CHECK". The FDA issued a decision of Substantially Equivalent on October 12, 2015. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Sysmex America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2015
- Date Received
- December 17, 2014
- 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