FDA 510(k), K200828, Athelas Home

FDA 510(k), K200828, Athelas Home

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
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
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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.

View full details