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FDA 510(k)

Great Basin Shiga Toxin Direct Test

K-Number: K152955 · 2016-03-22

ApplicantGreat Basin Scientific, Inc.
Decision Date2016-03-22
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Great Basin Shiga Toxin Direct Test is a medical device manufactured by Great Basin Scientific, Inc.. It received FDA 510(k) clearance on 2016-03-22 under approval number K152955. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Great Basin Shiga Toxin Direct Test?

Great Basin Shiga Toxin Direct Test is a medical device that received FDA 510(k) clearance on 2016-03-22. It is manufactured by Great Basin Scientific, Inc.. The 510(k) number is K152955.

When was Great Basin Shiga Toxin Direct Test approved by the FDA?

Great Basin Shiga Toxin Direct Test received FDA 510(k) clearance on 2016-03-22, under approval number K152955.

What company makes Great Basin Shiga Toxin Direct Test?

Great Basin Shiga Toxin Direct Test is manufactured by Great Basin Scientific, Inc..

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

The FDA product code for Great Basin Shiga Toxin Direct Test is PCH.

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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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