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FDA 510(k)

VIDAS RUB IGG

K-Number: K080766 · 2008-12-23

ApplicantbioMerieux, Inc.
Decision Date2008-12-23
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS RUB IGG is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K080766. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS RUB IGG?

VIDAS RUB IGG is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is bioMerieux, Inc.. The 510(k) number is K080766.

When did VIDAS RUB IGG receive FDA 510(k) clearance?

VIDAS RUB IGG received FDA 510(k) clearance on 2008-12-23, under 510(k) number K080766.

Who is the listed applicant for VIDAS RUB IGG?

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 RUB IGG?

The FDA product code for VIDAS RUB IGG is LFX.

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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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