INNOVANCE® D-Dimer 2.0 (SMN 10873803)
FDA 510(k) K253985 · Siemens Healthcare Diagnostic Products GmbH
510(k) numberK253985
Submission
- Device name
- INNOVANCE® D-Dimer 2.0 (SMN 10873803)
- Applicant
- Siemens Healthcare Diagnostic Products GmbH
Marburg, DE - Received
- December 12, 2025
- Decision date
- August 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7320
- Specialty
- Hematology
Other 510(k)s with product code DAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172903 | HemosIL D-Dimer HS 500DAP · Special | Instrumentation Laboratory CO | 11/22/2017SE |
| K162227 | STA® - Liatest® D-DiDAP · Traditional | Diagnostica Stago | 12/10/2016SE |
| K160885 | HemosIL D-Dimer HSDAP · Special | Instrumentation Laboratory CO | 10/27/2016SE |
| K151534 | HemosIL D-Dimer HSDAP · Special | Instrumentation Laboratory CO | 07/06/2015SE |
| K141144 | Sta Liatest D-DiDAP · Traditional | Diagnostica Stago | 09/03/2014SE |
| K112818 | Vidas D-Dimer Exclusion II (DEX2)DAP · Traditional | bioMerieux, Inc. | 07/31/2012SE |
| K110303 | Stratus CS Acute Care D-DimerDAP · Traditional | Siemens Healthcare Diagnostics | 05/16/2011SE |
| K093626 | Innovance D-Dimer, Model OPBP09DAP · Traditional | Siemens Healthcare Diagnostics | 11/29/2010SE |
| K090264 | Hemosil D-Dimer HS 500, ControlsDAP · Traditional | Instrumentation Laboratory CO | 02/05/2010SE |
| K091916 | Innovance D-Dimer, Model OPBP09DAP · Traditional | Siemens Healthcare Diagnostics | 10/29/2009SE |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K242952 | INNOVANCE AntithrombinJBQ · Traditional | 03/28/2025SE |
| K232624 | CardioPhase® hsCRPDCN · Traditional | 11/27/2023SE |
| K172286 | Automated Blood Coagulation Analyzer CS-2500JPA · Traditional | 12/18/2017SE |
| K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100JPA · Traditional | 01/11/2016SE |
Questions and answers
When was INNOVANCE® D-Dimer 2.0 (SMN 10873803) cleared by the FDA?
INNOVANCE® D-Dimer 2.0 (SMN 10873803) (K253985) received a 510(k) decision of Substantially Equivalent on August 11, 2026, 242 days after the submission was received.
What is the product code of K253985?
The FDA product code is DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 864.7320.