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FDA 510(k), K160538, Sysmex XN-L Automated Hematology Analyzer
FDA 510(k), K160538, Sysmex XN-L Automated Hematology Analyzer
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510(K) Number: K160538
Device Name: Sysmex XN-L Automated Hematology Analyzer
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 02/26/2016
Decision Date: 12/22/2016
Regulation Medical Specialty: Hematology
Device Name: Sysmex XN-L Automated Hematology Analyzer
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 02/26/2016
Decision Date: 12/22/2016
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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