FDA 510(k) Application Details - K221355

Device Classification Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)   More FDA Info for this Device
510(K) Number	K221355
Device Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant	Ortho Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF35 5PZ GB Other 510(k) Applications for this Company
Contact	Rebecca Lewis 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	05/10/2022
Decision Date	12/12/2022
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