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FDA 510(k), K143577, XW-100 Automated Hematology Analyzer, XW QC CHECK
FDA 510(k), K143577, XW-100 Automated Hematology Analyzer, XW QC CHECK
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510(K) Number: K143577
Device Name: XW-100 Automated Hematology Analyzer, XW QC CHECK
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: Counter, Differential Cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 12/17/2014
Decision Date: 10/12/2015
Regulation Medical Specialty: Hematology
Device Name: XW-100 Automated Hematology Analyzer, XW QC CHECK
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: Counter, Differential Cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 12/17/2014
Decision Date: 10/12/2015
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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