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FDA 510(k), K160429, BC-5390 Auto Hematology Analyzer
FDA 510(k), K160429, BC-5390 Auto Hematology Analyzer
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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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