FDA 510(k) Application Details - K213510

Device Classification Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)   More FDA Info for this Device
510(K) Number	K213510
Device Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant	Siemens Healthcare Diagnostics Products Ltd Glyn Rhonwy, Llanberis Caernarfon Llanberis LL55 4EL GB Other 510(k) Applications for this Company
Contact	Stefani Vinkemeier Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	LTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2021
Decision Date	09/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review