FDA 510(k) Application Details - K241919

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K241919
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	Innovita (Tangshan) Biological Technology CO., LTD 699 Juxin Street Qian'an 064400 CN Other 510(k) Applications for this Company
Contact	Yan Hua Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2024
Decision Date	08/02/2024
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