Cleared Traditional

Athelas Home

K200828 · Athelas, Inc. · Hematology

Mar 2022

Decision

722d

Days

Class 2

Risk

About This 510(k) Submission

K200828 is an FDA 510(k) clearance for the Athelas Home, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Athelas, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 22, 2022, 722 days after receiving the submission on March 30, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K200828 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2020
Decision Date	March 22, 2022
Days to Decision	722 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF