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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K200828
Device Name Athelas Home
Applicant
Athelas Inc.
67 E Evelyn Ave.
Mountain View,  CA  94041
Applicant Contact Tanay Tandon
Correspondent
Athelas Inc.
67 E Evelyn Ave.
Mountain View,  CA  94041
Correspondent Contact Tanay Tandon
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/30/2020
Decision Date 03/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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