K212743 is an FDA 510(k) clearance for the MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Medschenker, Inc. (Mahwah, US). The FDA issued a Cleared decision on May 3, 2023, 611 days after receiving the submission on August 30, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K212743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2021 |
| Decision Date | May 03, 2023 |
| Days to Decision | 611 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 |