FDA 510(k) Application Details - K233581

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K233581
Device Name	System, Test, Human Chorionic Gonadotropin
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	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	11/07/2023
Decision Date	05/08/2024
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