Cleared Traditional

Curian? Shiga Toxin

K222829 · Meridian Bioscience, Inc. · Microbiology
Apr 2023
Decision
210d
Days
Class 1
Risk

About This 510(k) Submission

K222829 is an FDA 510(k) clearance for the Curian? Shiga Toxin, a Antigens, All Types, Escherichia Coli (Class I — General Controls, product code GMZ), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 17, 2023, 210 days after receiving the submission on September 19, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K222829 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2022
Decision Date April 17, 2023
Days to Decision 210 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GMZ — Antigens, All Types, Escherichia Coli
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3255

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