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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
Predetermined Change
Control Plan Authorized		 No
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