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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 K243348
Device Name Athelas Home
Applicant
Athelas, Inc.
1300 Terra Bella Ave. Suite 200
Mountain View,  CA  94043
Applicant Contact Tanay Tandon
Correspondent
Athelas, Inc.
1300 Terra Bella Ave. Suite 200
Mountain View,  CA  94043
Correspondent Contact Nicole Clausen
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/28/2024
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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