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FDA 510(k)

AVC A/H5N1 FLU TEST

K-Number: K083278 · 2009-04-08

ApplicantArbor Vita Corportation
Decision Date2009-04-08
Product CodeOMS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AVC A/H5N1 FLU TEST is the device name listed in this FDA 510(k) record. The listed applicant is Arbor Vita Corportation. It received FDA 510(k) clearance on 2009-04-08 under 510(k) number K083278. The device is classified under product code OMS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVC A/H5N1 FLU TEST?

AVC A/H5N1 FLU TEST is a medical device that received FDA 510(k) clearance on 2009-04-08. The listed applicant is Arbor Vita Corportation. The 510(k) number is K083278.

When did AVC A/H5N1 FLU TEST receive FDA 510(k) clearance?

AVC A/H5N1 FLU TEST received FDA 510(k) clearance on 2009-04-08, under 510(k) number K083278.

Who is the listed applicant for AVC A/H5N1 FLU TEST?

The FDA 510(k) record lists Arbor Vita Corportation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVC A/H5N1 FLU TEST?

The FDA product code for AVC A/H5N1 FLU TEST is OMS.

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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