FDA 510(k) Application Details - K193318

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K193318
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Acon Laboratories Inc. 5850 Oberlin Drive #340 San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Qiyi Xie Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2019
Decision Date	08/20/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review