K233534 is an FDA 510(k) clearance for the Viral Transport Medium. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on August 2, 2024, 273 days after receiving the submission on November 3, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K233534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2023 |
| Decision Date | August 02, 2024 |
| Days to Decision | 273 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 |