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FDA 510(k), K032677, SYSMEX POCH-100I
FDA 510(k), K032677, SYSMEX POCH-100I
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510(K) Number: K032677
Device Name: SYSMEX POCH-100I
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: counter, cell, automated (particle counter)
Regulation Number: 864.5200
Classification Product Code: GKL
Date Received: 08/29/2003
Decision Date: 02/11/2004
Regulation Medical Specialty: Hematology
Device Name: SYSMEX POCH-100I
Manufacturer: SYSMEX AMERICA, INC.
Device Classification Name: counter, cell, automated (particle counter)
Regulation Number: 864.5200
Classification Product Code: GKL
Date Received: 08/29/2003
Decision Date: 02/11/2004
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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