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FDA 510(k), K200828, Athelas Home
FDA 510(k), K200828, Athelas Home
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510(K) Number: K200828
Device Name: Athelas Home
Manufacturer: Athelas Inc.
Device Classification Name: Counter, Differential Cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 03/30/2020
Decision Date: 03/22/2022
Regulation Medical Specialty: Hematology
Device Name: Athelas Home
Manufacturer: Athelas Inc.
Device Classification Name: Counter, Differential Cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 03/30/2020
Decision Date: 03/22/2022
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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