Copan Universal Transport Medium (UTM-RT) System
FDA 510(k) K232357 · Copan Italia Spa
510(k) numberK232357
Submission
- Device name
- Copan Universal Transport Medium (UTM-RT) System
- Applicant
- Copan Italia Spa
Brescia, IT - Received
- August 7, 2023
- Decision date
- April 25, 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 |
| K220908 | Ensol EnTM Specimen Collection and Transport SystemJSM · Traditional | Ensol Biosciences, Inc. | 08/29/2024SE |
| 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 |
| K202531 | Azer Scientific Universal Transport MediumJSM · Traditional | Azer Scientific, Inc. | 04/11/2024SE |
More from Azer Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232565 | UriSpongeJSM · Traditional | 10/11/2024SE |
| K220052 | Copan FecalSwab Collection, Transport and Preservation SystemJSM · Traditional | 12/16/2022SE |
| K201849 | eNAT molecular collection and preservation mediumQBD · Traditional | 09/17/2020SE |
| K180052 | UriSwab-Urine Collection, Transport and Preservation SystemJSM · Traditional | 03/23/2018SE |
| K142094 | Copan Fecalswab Collection, Transport and Preservation SystemJSM · Traditional | 04/10/2015SE |
| K972449 | Copan Venturi Transystem Amies Medium with CharcoalJSL · Traditional | 08/20/1997SE |
| K972448 | Copan Venturi Transystem Amies Medium Without CharcoalJSL · Traditional | 08/20/1997SE |
Questions and answers
When was Copan Universal Transport Medium (UTM-RT) System cleared by the FDA?
Copan Universal Transport Medium (UTM-RT) System (K232357) received a 510(k) decision of Substantially Equivalent on April 25, 2024, 262 days after the submission was received.
What is the product code of K232357?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.