FDA 510(k) Application Details - K233946

Device Classification Name	System, Test, Immunological, Antigen, Tumor   More FDA Info for this Device
510(K) Number	K233946
Device Name	System, Test, Immunological, Antigen, Tumor
Applicant	Siemens Healthcare Diagnostics Products Ltd Glyn Rhonwy, Llanberis Caernarfon Llanberis LL55 4EL GB Other 510(k) Applications for this Company
Contact	Karlyn Kellogg Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2023
Decision Date	03/13/2024
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