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FDA 510(k)

Accula Flu A/Flu B Test

K-Number: K171641 · 2018-02-06

ApplicantMesa Biotech, Inc.
Decision Date2018-02-06
Product CodeOZE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Accula Flu A/Flu B Test is a medical device manufactured by Mesa Biotech, Inc.. It received FDA 510(k) clearance on 2018-02-06 under approval number K171641. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accula Flu A/Flu B Test?

Accula Flu A/Flu B Test is a medical device that received FDA 510(k) clearance on 2018-02-06. It is manufactured by Mesa Biotech, Inc.. The 510(k) number is K171641.

When was Accula Flu A/Flu B Test approved by the FDA?

Accula Flu A/Flu B Test received FDA 510(k) clearance on 2018-02-06, under approval number K171641.

What company makes Accula Flu A/Flu B Test?

Accula Flu A/Flu B Test is manufactured by Mesa Biotech, Inc..

What is the FDA product code for Accula Flu A/Flu B Test?

The FDA product code for Accula Flu A/Flu B Test is OZE.

Other Devices by Mesa Biotech, Inc.

K181443Accula RSV Test K201269Accula Strep A Test

Related Devices (Code: OZE)

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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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