AllTest Viral Transport Medium
FDA 510(k) K242576 · Hangzhou AllTest Biotech Co., Ltd.
510(k) numberK242576
Submission
- Device name
- AllTest Viral Transport Medium
- Applicant
- Hangzhou AllTest Biotech Co., Ltd.
Hangzhou, CN - Received
- August 29, 2024
- Decision date
- April 4, 2025
- 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 |
| 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 |
| 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 |
More from Azer Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260342 | AllTest Strep A Rapid TestGTY · Traditional | 04/30/2026SE |
| K252607 | AllTest Urinary Tract Infection TestJMT · Traditional | 10/30/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | 07/15/2025SE |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional | 04/04/2025SE |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT · Traditional | 02/27/2025SE |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFT · Traditional | 09/27/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | 08/13/2024SE |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFT · Traditional | 06/17/2024SE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…DKZ · Traditional | 12/13/2023SE |
| K233417 | AllTest Fentanyl Urine Test CassetteNGL · Traditional | 10/26/2023SE |
Questions and answers
When was AllTest Viral Transport Medium cleared by the FDA?
AllTest Viral Transport Medium (K242576) received a 510(k) decision of Substantially Equivalent on April 4, 2025, 218 days after the submission was received.
What is the product code of K242576?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.