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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K242952
Device Name INNOVANCE Antithrombin
Applicant
Siemens Healthcare Diagnostic Products GmbH
Emil-Von-Behring Strasse 76
Marburg,  DE 35041
Applicant Contact Martina Pfeiff
Correspondent
Siemens Healthcare Diagnostic Products GmbH
Emil-Von-Behring Strasse 76
Marburg,  DE 35041
Correspondent Contact Martina Pfeiff
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received09/25/2024
Decision Date 03/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03754790
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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