FDA 510(k) Application Details - K210017

Device Classification Name	More FDA Info for this Device
510(K) Number	K210017
Device Name	ACTOnco, ACTOnco IVD
Applicant	ACT Genomics 3F, No 345, Xinhu 2nd Road., Neihu District Taipei 11494 TW Other 510(k) Applications for this Company
Contact	Pei-Fang Chung Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2021
Decision Date	12/23/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review