Copan Venturi Transystem Amies Medium with Charcoal
FDA 510(k) K972449 · Copan Italia Spa
510(k) numberK972449
Submission
- Device name
- Copan Venturi Transystem Amies Medium with Charcoal
- Applicant
- Copan Italia Spa
North Attleboro, MA, US - Received
- June 30, 1997
- Decision date
- August 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JSL – Culture Media, Anaerobic Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
Other 510(k)s with product code JSL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972448 | Copan Venturi Transystem Amies Medium Without CharcoalJSL · Traditional | Copan Italia Spa | 08/20/1997SE |
| K944847 | Kultsure/Starswab Anaerobic Transport SystemJSL · Traditional | Starplex Scientific, Inc. | 02/16/1995SE |
| K925450 | Bionor TransportmediumJSL · Traditional | Skoug Research Corp. | 06/25/1993SE |
| K841220 | Anaerobic Transport MediumJSL · Traditional | Anaerobe Systems | 04/04/1984SE |
| K834357 | Ana Trans Tube & Swabs Sterile PackJSL · Traditional | Anaerobe Systems | 01/31/1984SE |
| K770840 | Pre-Reduced Anaerobic MediaJSL · Traditional | Gibco Laboratories Life Technologies, Inc. | 06/08/1977SE |
| K770650 | Pre-Duced Culture MediaJSL · Traditional | Gibco Laboratories Life Technologies, Inc. | 04/15/1977SE |
More from Gibco Laboratories Life Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232565 | UriSpongeJSM · Traditional | 10/11/2024SE |
| K232357 | Copan Universal Transport Medium (UTM-RT) SystemJSM · Traditional | 04/25/2024SE |
| 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 |
| K972448 | Copan Venturi Transystem Amies Medium Without CharcoalJSL · Traditional | 08/20/1997SE |
Questions and answers
When was Copan Venturi Transystem Amies Medium with Charcoal cleared by the FDA?
Copan Venturi Transystem Amies Medium with Charcoal (K972449) received a 510(k) decision of Substantially Equivalent on August 20, 1997, 51 days after the submission was received.
What is the product code of K972449?
The FDA product code is JSL – Culture Media, Anaerobic Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.