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FDA 510(k)

STRATUS CS ACUTE CARE D-DIMER

K-Number: K110303 · 2011-05-16

ApplicantSiemens Healthcare Diagnostics
Decision Date2011-05-16
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STRATUS CS ACUTE CARE D-DIMER 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 2011-05-16 under 510(k) number K110303. 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 STRATUS CS ACUTE CARE D-DIMER?

STRATUS CS ACUTE CARE D-DIMER is a medical device that received FDA 510(k) clearance on 2011-05-16. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K110303.

When did STRATUS CS ACUTE CARE D-DIMER receive FDA 510(k) clearance?

STRATUS CS ACUTE CARE D-DIMER received FDA 510(k) clearance on 2011-05-16, under 510(k) number K110303.

Who is the listed applicant for STRATUS CS ACUTE CARE D-DIMER?

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 STRATUS CS ACUTE CARE D-DIMER?

The FDA product code for STRATUS CS ACUTE CARE D-DIMER 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.K093626INNOVANCE D-DIMER, MODEL OPBP09Siemens 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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