K232357 is an FDA 510(k) clearance for the Copan Universal Transport Medium (UTM-RT) System. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Copan Italia Spa (Brescia, IT). The FDA issued a Cleared decision on April 25, 2024, 262 days after receiving the submission on August 7, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K232357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2023 |
| Decision Date | April 25, 2024 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JSM - Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |