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FDA 510(k)

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

K-Number: K081732 · 2008-10-24

ApplicantSiemens Healthcare Diagnostics
Decision Date2008-10-24
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2008-10-24 under 510(k) number K081732. 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 AND INNOVANCE D-DIMER CONTROLS?

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS is a medical device that received FDA 510(k) clearance on 2008-10-24. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K081732.

When did INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS receive FDA 510(k) clearance?

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS received FDA 510(k) clearance on 2008-10-24, under 510(k) number K081732.

Who is the listed applicant for INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS?

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

What is the FDA product code for INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS?

The FDA product code for INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS is DAP.

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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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbHK172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica StagoK160885HemosIL D-Dimer HSInstrumentation Laboratory COK112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare Diagnostics

Official Source

View on FDA Database →

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

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