K231027 is an FDA 510(k) clearance for the KaiBiLi Extended ViralTrans. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 21, 2023, 254 days after receiving the submission on April 11, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K231027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2023 |
| Decision Date | December 21, 2023 |
| Days to Decision | 254 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 |