FDA 510(k) Application Details - K213626

Device Classification Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer   More FDA Info for this Device
510(K) Number	K213626
Device Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Applicant	Ortho Clinical Diagnostics Felindre Meadows Pencoed CF35 5PZ GB Other 510(k) Applications for this Company
Contact	Declan Hynes Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	LOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2021
Decision Date	06/15/2022
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