FDA 510(k), K143577, XW-100 Automated Hematology Analyzer, XW QC CHECK

510(K) Number: K143577
Device Name: XW-100 Automated Hematology Analyzer, XW QC CHECK
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: Counter, Differential Cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 12/17/2014
Decision Date: 10/12/2015
Regulation Medical Specialty: Hematology

75 pages (3,388 of 3,463 original pages are fully redacted and most removed)