FDA 510(k) Application Details - K223690

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K223690
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	Shenzhen YHLO Biotech Co., LTD. Building 1, YHLO Biopark, Baolong 2nd Road Baolong Subdistrict, Longgang District Shenzhen 518116 CN Other 510(k) Applications for this Company
Contact	Ying Dai Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2022
Decision Date	12/11/2023
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