FDA 510(k) Application Details - K212379

Device Classification Name	Kappa, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K212379
Device Name	Kappa, Antigen, Antiserum, Control
Applicant	Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Str. 76 Marburg 35041 DE Other 510(k) Applications for this Company
Contact	Martina Pfeiff Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2021
Decision Date	03/02/2022
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