INNOVANCE® D-Dimer 2.0 (SMN 10873803)— 510(k) K253985

Name: FDA 510(k) clearance K253985
Creator: U.S. Food and Drug Administration
Published: 2026-08-11

Substantially Equivalent

Siemens Healthcare Diagnostic Products GmbH

FDA 510(k) clearance K253985 for INNOVANCE® D-Dimer 2.0 (SMN 10873803), Substantially Equivalent on 2026-08-11. Applicant: Siemens Healthcare Diagnostic Products GmbH. Device class: 2.

Summary

Siemens Healthcare Diagnostic Products filed INNOVANCE D-Dimer 2.0, listed as SMN 10873803, under product code DAP: fibrinogen and fibrin split products, antigen, antiserum, control.

Class II, 21 CFR 864.7320. Hematology is both the classification panel and the review panel. It was a Traditional 510(k).

Siemens filed from Marburg, Germany. The substantially equivalent decision came 242 calendar days after receipt (December 12, 2025 to August 11, 2026).

Clearance details

Applicant: Siemens Healthcare Diagnostic Products GmbH
Product code: Product code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2025-12-12
Decision date: 2026-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marburg, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.