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FDA 510(k)

VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442

K-Number: K020810 · 2002-10-03

ApplicantbioMerieux, Inc.
Decision Date2002-10-03
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2002-10-03 under 510(k) number K020810. 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 NEW (DD2) ASSAY MODEL#30 442?

VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 is a medical device that received FDA 510(k) clearance on 2002-10-03. The listed applicant is bioMerieux, Inc.. The 510(k) number is K020810.

When did VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 receive FDA 510(k) clearance?

VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 received FDA 510(k) clearance on 2002-10-03, under 510(k) number K020810.

Who is the listed applicant for VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442?

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 NEW (DD2) ASSAY MODEL#30 442?

The FDA product code for VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 is DAP.

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Related Devices (Code: 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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