FDA 510(k), K160429, BC-5390 Auto Hematology Analyzer

510(K) Number: K160429
Device Name: BC-5390 Auto Hematology Analyzer
Manufacturer: MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 02/16/2016
Decision Date: 09/01/2016
Regulation Medical Specialty: Hematology

Total pages: 8499
Fully redacted pages: 7703
Content pages: 796