Ensol EnTM Specimen Collection and Transport System
FDA 510(k) K220908 · Ensol Biosciences, Inc.
510(k) numberK220908
Submission
- Device name
- Ensol EnTM Specimen Collection and Transport System
- Applicant
- Ensol Biosciences, Inc.
Daejeon, KR - Received
- March 29, 2022
- Decision date
- August 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JSM – Culture Media, Non-Propagating Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
Other 510(k)s with product code JSM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceJSM · Traditional | Medical Wire & Equipment Company (Bath), Ltd. | 11/26/2025SE |
| K250205 | Babio® Virus Transport Kit (Non-inactivating)JSM · Traditional | Jinan Babio Biotechnology Co., Ltd. | 09/22/2025SE |
| K242576 | AllTest Viral Transport MediumJSM · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/04/2025SE |
| K232565 | UriSpongeJSM · Traditional | Copan Italia Spa | 10/11/2024SE |
| K240235 | OmniTrans Transport SystemJSM · Traditional | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 08/19/2024SE |
| K233534 | Viral Transport MediumJSM · Traditional | Hardy Diagnostics | 08/02/2024SE |
| K233449 | Avantik VTMJSM · Traditional | Hanchang Medic Co., Ltd. (Han Chang Medic) | 07/15/2024SE |
| K232454 | Viral Transport Media (VTM)JSM · Traditional | Alb Luz | 05/03/2024SE |
| K232357 | Copan Universal Transport Medium (UTM-RT) SystemJSM · Traditional | Copan Italia Spa | 04/25/2024SE |
| K202531 | Azer Scientific Universal Transport MediumJSM · Traditional | Azer Scientific, Inc. | 04/11/2024SE |
Questions and answers
When was Ensol EnTM Specimen Collection and Transport System cleared by the FDA?
Ensol EnTM Specimen Collection and Transport System (K220908) received a 510(k) decision of Substantially Equivalent on August 29, 2024, 884 days after the submission was received.
What is the product code of K220908?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.