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FDA 510(k)

Curian® Shiga Toxin

K-Number: K222829 · 2023-04-17

ApplicantMeridian Bioscience, Inc.
Decision Date2023-04-17
Product CodeGMZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Curian® Shiga Toxin is a medical device manufactured by Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2023-04-17 under approval number K222829. The device is classified under product code GMZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curian® Shiga Toxin?

Curian® Shiga Toxin is a medical device that received FDA 510(k) clearance on 2023-04-17. It is manufactured by Meridian Bioscience, Inc.. The 510(k) number is K222829.

When was Curian® Shiga Toxin approved by the FDA?

Curian® Shiga Toxin received FDA 510(k) clearance on 2023-04-17, under approval number K222829.

What company makes Curian® Shiga Toxin?

Curian® Shiga Toxin is manufactured by Meridian Bioscience, Inc..

What is the FDA product code for Curian® Shiga Toxin?

The FDA product code for Curian® Shiga Toxin is GMZ.

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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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