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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Next Generation Sequencing Based Tumor Profiling Test
510(k) Number K210017
Device Name ACTOnco, ACTOnco IVD
Applicant
Act Genomics
3f, No 345, Xinhu 2nd Rd.., Neihu District
Taipei,  TW 11494
Applicant Contact Pei-Fang Chung
Correspondent
K2 Regulatory Consulting, LLC
479 Cumberland Dr.
Burlingame,  CA  94010
Correspondent Contact David Kern
Regulation Number866.6080
Classification Product Code
PZM  
Date Received01/04/2021
Decision Date 12/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
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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