K222829 is an FDA 510(k) clearance for the Curian® Shiga Toxin. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3255.
| 510(k) Number | K222829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | GMZ — Antigens, All Types, Escherichia Coli |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3255 |