JSM
- Product code
- JSM
- Device name
- Culture Media, Non-Propagating Transport
- Device class
- Class 1
- 21 CFR
- 21 CFR 866.2390
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 13
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 111 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (13)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242976 | 2025-11-26 | Medical Wire & Equipment Company (Bath… | Medical Wire Fecal Transwab Liquid Cary Blair Medium… | |
| K250205 | 2025-09-22 | Jinan Babio Biotechnology Co., Ltd. | Babio® Virus Transport Kit (Non-inactivating) | — |
| K242576 | 2025-04-04 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Viral Transport Medium | |
| K232565 | 2024-10-11 | Copan Italia Spa | UriSponge | FDA |
| K220908 | 2024-08-29 | Ensol Biosciences, Inc. | Ensol EnTM Specimen Collection and Transport System | |
| K240235 | 2024-08-19 | Shenzhen Dakewe Bio-Engineering Co., L… | OmniTrans Transport System | |
| K233534 | 2024-08-02 | Hardy Diagnostics | Viral Transport Medium | |
| K233449 | 2024-07-15 | Hanchang Medic Co., Ltd. (Han Chang Me… | Avantik VTM | |
| K232454 | 2024-05-03 | Alb Luz | Viral Transport Media (VTM) | |
| K232357 | 2024-04-25 | Copan Italia Spa | Copan Universal Transport Medium (UTM-RT) System | |
| K202531 | 2024-04-11 | Azer Scientific, Inc. | Azer Scientific Universal Transport Medium | |
| K231843 | 2024-03-19 | Arx Sciences, Inc. | ARX Viral Transport Media Collection and Transport S… | |
| K231027 | 2023-12-21 | Hangzhou Genesis Biodetection & Biocon… | KaiBiLi Extended ViralTrans |
Official FDA classification page: JSM
Classification and pathway per current FDA publications. Data from openFDA (CC0).