FDA 510(k) Application Details - K242952

Device Classification Name	Antithrombin Iii Quantitation   More FDA Info for this Device
510(K) Number	K242952
Device Name	Antithrombin Iii Quantitation
Applicant	Siemens Healthcare Diagnostic Products GmbH Emil-von-Behring Strasse 76 Marburg 35041 DE Other 510(k) Applications for this Company
Contact	Martina Pfeiff Other 510(k) Applications for this Contact
Regulation Number	864.7060   More FDA Info for this Regulation Number
Classification Product Code	JBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2024
Decision Date	03/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review