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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 K181288
Device Name Athelas One
Athelas Inc.
10209 Danube Dr.
Cupertino,  CA  95014
Applicant Contact Tanay Tandon
Athelas Inc.
10209 Danube Dr.
Cupertino,  CA  95014
Correspondent Contact Tanay Tandon
Regulation Number864.5220
Classification Product Code
Date Received05/16/2018
Decision Date 11/05/2018
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