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.

Clearance details

Applicant: Siemens Healthcare Diagnostic Products GmbH
Product code: 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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K151534 — HemosIL D-Dimer HS2015-07-06
K141144 — STA LIATEST D-DI2014-09-03

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