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FDA 510(k)

NUCLISENS EASYQ ENTEROVIRUS SYSTEM

K-Number: K063261 · 2008-06-23

ApplicantbioMerieux, Inc.
Decision Date2008-06-23
Product CodeOAI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NUCLISENS EASYQ ENTEROVIRUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2008-06-23 under 510(k) number K063261. The device is classified under product code OAI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLISENS EASYQ ENTEROVIRUS SYSTEM?

NUCLISENS EASYQ ENTEROVIRUS SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-23. The listed applicant is bioMerieux, Inc.. The 510(k) number is K063261.

When did NUCLISENS EASYQ ENTEROVIRUS SYSTEM receive FDA 510(k) clearance?

NUCLISENS EASYQ ENTEROVIRUS SYSTEM received FDA 510(k) clearance on 2008-06-23, under 510(k) number K063261.

Who is the listed applicant for NUCLISENS EASYQ ENTEROVIRUS SYSTEM?

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 NUCLISENS EASYQ ENTEROVIRUS SYSTEM?

The FDA product code for NUCLISENS EASYQ ENTEROVIRUS SYSTEM is OAI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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