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FDA 510(k)

Great Basin Bordetella Direct Test

K-Number: K170284 · 2017-03-31

ApplicantGreat Basin Scientific, Inc.
Decision Date2017-03-31
Product CodeOZZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Great Basin Bordetella Direct Test is a medical device manufactured by Great Basin Scientific, Inc.. It received FDA 510(k) clearance on 2017-03-31 under approval number K170284. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Great Basin Bordetella Direct Test?

Great Basin Bordetella Direct Test is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Great Basin Scientific, Inc.. The 510(k) number is K170284.

When was Great Basin Bordetella Direct Test approved by the FDA?

Great Basin Bordetella Direct Test received FDA 510(k) clearance on 2017-03-31, under approval number K170284.

What company makes Great Basin Bordetella Direct Test?

Great Basin Bordetella Direct Test is manufactured by Great Basin Scientific, Inc..

What is the FDA product code for Great Basin Bordetella Direct Test?

The FDA product code for Great Basin Bordetella Direct Test is OZZ.

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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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