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FDA 510(k), K181288, Athelas One
FDA 510(k), K181288, Athelas One
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510(K) Number: K181288
Device Name: Athelas One
Manufacturer: Athelas Inc.
Device Classification Name: Counter, Differential Cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 05/16/2018
Decision Date: 11/05/2018
Regulation Medical Specialty: Hematology
Device Name: Athelas One
Manufacturer: Athelas Inc.
Device Classification Name: Counter, Differential Cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 05/16/2018
Decision Date: 11/05/2018
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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