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FDA 510(k), K172604, XW-100 Automated Hematology Analyzer for CLIA Waived Use
FDA 510(k), K172604, XW-100 Automated Hematology Analyzer for CLIA Waived Use
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510(K) Number: K172604
Device Name: XW-100 Automated Hematology Analyzer for CLIA Waived Use
Manufacturer: Sysmex America, Inc.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 08/30/2017
Decision Date: 11/06/2017
Regulation Medical Specialty: Hematology
Device Name: XW-100 Automated Hematology Analyzer for CLIA Waived Use
Manufacturer: Sysmex America, Inc.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 08/30/2017
Decision Date: 11/06/2017
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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