FDA 510(k) Application Details - K212559

Device Classification Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K212559
Device Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And 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	866.5270   More FDA Info for this Regulation Number
Classification Product Code	NQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2021
Decision Date	12/16/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review