CVM Transport, Model R96,VIRAL Transport, Model R99, CVM Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K
FDA 510(k) K993812 · Hardy Diagnostics
510(k) numberK993812
Submission
- Device name
- CVM Transport, Model R96,VIRAL Transport, Model R99, CVM Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K
- Applicant
- Hardy Diagnostics
Santa Maria, CA, US - Received
- November 10, 1999
- Decision date
- December 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
| K232357 | Copan Universal Transport Medium (UTM-RT) SystemJSM · Traditional | Copan Italia Spa | 04/25/2024SE |
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| K233534 | Viral Transport MediumJSM · Traditional | 08/02/2024SE |
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Questions and answers
When was CVM Transport, Model R96,VIRAL Transport, Model R99, CVM Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K cleared by the FDA?
CVM Transport, Model R96,VIRAL Transport, Model R99, CVM Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K (K993812) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 41 days after the submission was received.
What is the product code of K993812?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.