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FDA 510(k) K160429, BC-5390 Auto Hematology Analyzer, by Mindray Bio-Medical Electronics Co., Ltd.

FDA 510(k) K160429, BC-5390 Auto Hematology Analyzer, by Mindray Bio-Medical Electronics Co., Ltd.

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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

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