Copan Venturi Transystem Cary-Blair Medium
FDA 510(k) K946286 · Copan Diagnostics, Inc.
510(k) numberK946286
Submission
- Device name
- Copan Venturi Transystem Cary-Blair Medium
- Applicant
- Copan Diagnostics, Inc.
North Attleboro, MA, US - Received
- December 27, 1994
- Decision date
- March 10, 1995
- 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
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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 |
More from Copan Italia Spa
| 510(k) | Device | Decision |
|---|---|---|
| K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemJTW · Traditional | 06/23/2006SE |
| K042970 | Copan Universal Transport Medium (Utm-Rt) SystemJSM · Traditional | 12/07/2004SE |
| K001780 | Copan Viral TransystemJSM · Traditional | 07/31/2001SE |
| K993161 | Copan Easy-Swab Collection and Transport SystemJTW · Traditional | 11/09/1999SE |
| K946288 | Copan Venturi Transystem Liquid Amies MediumJSM · Traditional | 03/10/1995SE |
| K946287 | Copan Venturi Transystem Amies Medium Without CharcoalJSM · Traditional | 03/10/1995SE |
| K946285 | Copan Venturi Transystem Stuarts MediumJSM · Traditional | 03/10/1995SE |
| K946284 | Copan Venturi Transystem Amies Medium with CharcoalJSM · Traditional | 03/10/1995SE |
| K946283 | Copan Venturi Transystem Liquid Stuarts MediumJSM · Traditional | 03/10/1995SE |
Questions and answers
When was Copan Venturi Transystem Cary-Blair Medium cleared by the FDA?
Copan Venturi Transystem Cary-Blair Medium (K946286) received a 510(k) decision of Substantially Equivalent on March 10, 1995, 73 days after the submission was received.
What is the product code of K946286?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.