FDA 510(k), K112605, SYSMEX XN-SERIES

510(K) Number: K112605
Device Name: SYSMEX XN-SERIES
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 09/07/2011
Decision Date: 10/19/2012
Regulation Medical Specialty: Hematology

Total pages: 7,025
Fully redacted pages: 6,275
Content pages: 750