FDA 510(k), K992875, SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
FDA 510(k), K992875, SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
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510(K) Number: K992875
Device Name: SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
Manufacturer: SYSMEX CORP.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 08/26/1999
Decision Date: 11/09/1999
Regulation Medical Specialty: Hematology
Device Name: SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
Manufacturer: SYSMEX CORP.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 08/26/1999
Decision Date: 11/09/1999
Regulation Medical Specialty: Hematology
- 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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