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FDA 510(k), K112605, SYSMEX XN-SERIES
FDA 510(k), K112605, SYSMEX XN-SERIES
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510(K) Number: K112605
Device Name: SYSMEX XN-SERIES
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 09/07/2011
Decision Date: 10/19/2012
Regulation Medical Specialty: Hematology
Device Name: SYSMEX XN-SERIES
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 09/07/2011
Decision Date: 10/19/2012
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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