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FDA 510(k)

VIDAS D-DIMER EXCLUSION II (DEX2)

K-Number: K112818 · 2012-07-31

ApplicantbioMerieux, Inc.
Decision Date2012-07-31
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VIDAS D-DIMER EXCLUSION II (DEX2) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2012-07-31 under 510(k) number K112818. 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 VIDAS D-DIMER EXCLUSION II (DEX2)?

VIDAS D-DIMER EXCLUSION II (DEX2) is a medical device that received FDA 510(k) clearance on 2012-07-31. The listed applicant is bioMerieux, Inc.. The 510(k) number is K112818.

When did VIDAS D-DIMER EXCLUSION II (DEX2) receive FDA 510(k) clearance?

VIDAS D-DIMER EXCLUSION II (DEX2) received FDA 510(k) clearance on 2012-07-31, under 510(k) number K112818.

Who is the listed applicant for VIDAS D-DIMER EXCLUSION II (DEX2)?

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

What is the FDA product code for VIDAS D-DIMER EXCLUSION II (DEX2)?

The FDA product code for VIDAS D-DIMER EXCLUSION II (DEX2) is DAP.

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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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