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FDA 510(k)

ADVANCED D-DIMER ASSAY

K-Number: K041438 · 2004-08-11

ApplicantDade Behring, Inc.
Decision Date2004-08-11
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADVANCED D-DIMER ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2004-08-11 under 510(k) number K041438. 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 ADVANCED D-DIMER ASSAY?

ADVANCED D-DIMER ASSAY is a medical device that received FDA 510(k) clearance on 2004-08-11. The listed applicant is Dade Behring, Inc.. The 510(k) number is K041438.

When did ADVANCED D-DIMER ASSAY receive FDA 510(k) clearance?

ADVANCED D-DIMER ASSAY received FDA 510(k) clearance on 2004-08-11, under 510(k) number K041438.

Who is the listed applicant for ADVANCED D-DIMER ASSAY?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANCED D-DIMER ASSAY?

The FDA product code for ADVANCED D-DIMER ASSAY 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.

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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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