K201674 is an FDA 510(k) clearance for the Cultura Collection and Transport System. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 3, 2021, 257 days after receiving the submission on June 19, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K201674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2020 |
| Decision Date | March 03, 2021 |
| Days to Decision | 257 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 |