FDA 510(k) Application Details - K240315

Device Classification Name	More FDA Info for this Device
510(K) Number	K240315
Device Name	INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
Applicant	Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Strasse 76 Marburg 35041 DE Other 510(k) Applications for this Company
Contact	Anja Wilhelm Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2024
Decision Date	10/10/2024
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