Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K253985
Device Name INNOVANCE® D-Dimer 2.0 (SMN 10873803)
Applicant
Siemens Healthcare Diagnostic Products GmbH
Emil-Von-Behring Strasse 76
Marburg,  DE 35041
Applicant Contact Petra Maria Dissmann
Correspondent
Siemens Healthcare Diagnostic Products GmbH
Emil-Von-Behring Strasse 76
Marburg,  DE 35041
Correspondent Contact Petra Maria Dissmann
Regulation Number864.7320
Classification Product Code
DAP  
Date Received12/12/2025
Decision Date 08/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-