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FDA 510(k)

INNOVANCE® D-Dimer 2.0 (SMN 10873803)

K-Number: K253985 · 2026-08-11

ApplicantSiemens Healthcare Diagnostic Products GmbH
Decision Date2026-08-11
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INNOVANCE® D-Dimer 2.0 (SMN 10873803) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2026-08-11 under 510(k) number K253985. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVANCE® D-Dimer 2.0 (SMN 10873803)?

INNOVANCE® D-Dimer 2.0 (SMN 10873803) is a medical device that received FDA 510(k) clearance on 2026-08-11. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K253985.

When did INNOVANCE® D-Dimer 2.0 (SMN 10873803) receive FDA 510(k) clearance?

INNOVANCE® D-Dimer 2.0 (SMN 10873803) received FDA 510(k) clearance on 2026-08-11, under 510(k) number K253985.

Who is the listed applicant for INNOVANCE® D-Dimer 2.0 (SMN 10873803)?

The FDA 510(k) record lists Siemens Healthcare Diagnostic Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVANCE® D-Dimer 2.0 (SMN 10873803)?

The FDA product code for INNOVANCE® D-Dimer 2.0 (SMN 10873803) is DAP.

Other records listing Siemens Healthcare Diagnostic Products GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242952INNOVANCE AntithrombinK232624CardioPhase® hsCRPK172286Automated Blood Coagulation Analyzer CS-2500K150678Sysmex Automated Blood Coagulation Analyzer CS-5100

Related Devices (Code: DAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica StagoK160885HemosIL D-Dimer HSInstrumentation Laboratory CO

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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