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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Factor Xa Activity Test System, Apixaban
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,  DE 35041
Applicant Contact Anja Wilhelm
Correspondent
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring-Strasse 76
Marburg,  DE 35041
Correspondent Contact Anja Wilhelm
Regulation Number864.7295
Classification Product Code
QLU  
Date Received02/02/2024
Decision Date 10/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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