K231843 is an FDA 510(k) clearance for the ARX Viral Transport Media Collection and Transport System. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Arx Sciences, Inc. (Amherst, US). The FDA issued a Cleared decision on March 19, 2024, 271 days after receiving the submission on June 22, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K231843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2023 |
| Decision Date | March 19, 2024 |
| Days to Decision | 271 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 |