K212856 is an FDA 510(k) clearance for the iClean Viral Transport System (VTM-RT kit). This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Huachenyang (Shenzhen) Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 18, 2022, 344 days after receiving the submission on September 8, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K212856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2021 |
| Decision Date | August 18, 2022 |
| Days to Decision | 344 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 |