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510(k) K253985

INNOVANCE® D-Dimer 2.0 (SMN 10873803) by Siemens Healthcare Diagnostic Products GmbH — Product Code DAP

K253985 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostic Products GmbH for the device "INNOVANCE® D-Dimer 2.0 (SMN 10873803)". The FDA issued a decision of Substantially Equivalent on August 11, 2026. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. Siemens Healthcare Diagnostic Products GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2026
Date Received
December 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

Other clearances by Siemens Healthcare Diagnostic Products GmbH

  • K242952 — INNOVANCE Antithrombin (March 28, 2025)
  • K232624 — CardioPhase® hsCRP (November 27, 2023)
  • K172286 — Automated Blood Coagulation Analyzer CS-2500 (December 18, 2017)
  • K150678 — Sysmex Automated Blood Coagulation Analyzer CS-5100 (January 11, 2016)

Other clearances for product code DAP

  • K172903 — HemosIL D-Dimer HS 500 (November 22, 2017)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K160885 — HemosIL D-Dimer HS (October 27, 2016)
  • K151534 — HemosIL D-Dimer HS (July 6, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K112818 — VIDAS D-DIMER EXCLUSION II (DEX2) (July 31, 2012)
  • K110303 — STRATUS CS ACUTE CARE D-DIMER (May 16, 2011)
  • K093626 — INNOVANCE D-DIMER, MODEL OPBP09 (November 29, 2010)
  • K090264 — HEMOSIL D-DIMER HS 500, CONTROLS (February 5, 2010)
  • K091916 — INNOVANCE D-DIMER, MODEL OPBP09 (October 29, 2009)

FDA data resources