FDA 510(k) Application Details - K203246

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K203246
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Atlas Link Technology Co., Ltd. Gu'an South Industry Zone Langfang 065500 CN Other 510(k) Applications for this Company
Contact	Xiaoping Hao 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	11/04/2020
Decision Date	08/04/2021
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