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FDA 510(k), K180020, HemoScreen Hematology Analyzer
FDA 510(k), K180020, HemoScreen Hematology Analyzer
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510(K) Number: K180020
Device Name: HemoScreen Hematology Analyzer
Manufacturer: PixCell Medical Technologies, Ltd.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 01/02/2018
Decision Date: 10/29/2018
Regulation Medical Specialty: Hematology
Device Name: HemoScreen Hematology Analyzer
Manufacturer: PixCell Medical Technologies, Ltd.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 01/02/2018
Decision Date: 10/29/2018
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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