FDA 510(k) Application Details - K232624

Device Classification Name	System, Test, C-Reactive Protein   More FDA Info for this Device
510(K) Number	K232624
Device Name	System, Test, C-Reactive Protein
Applicant	Siemens Healthcare Diagnostic Products GmbH Emil-von Behring Strasse 76 Marburg 35041 DE Other 510(k) Applications for this Company
Contact	Petra Dissmann Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2023
Decision Date	11/27/2023
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