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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 the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2023-04-17 under 510(k) 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. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K222829.

When did Curian® Shiga Toxin receive FDA 510(k) clearance?

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

Who is the listed applicant for Curian® Shiga Toxin?

The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Meridian Bioscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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