Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System
FDA 510(k) K061301 · Copan Diagnostics, Inc.
510(k) numberK061301
Submission
- Device name
- Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System
- Applicant
- Copan Diagnostics, Inc.
North Attleboro, MA, US - Received
- May 10, 2006
- Decision date
- June 23, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JTW – System, Transport, Aerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
Other 510(k)s with product code JTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121039 | Copan Mswab Collection, Transport and Preservation SystemJTW · Traditional | Copan Flock Technologies | 05/25/2012SE |
| K022874 | Gen-Probe Aptima Combo 2 AssayJTW · Traditional | Gen-Probe, Inc. | 09/17/2002SE |
| K013819 | Urine Collection, Preservation and Transport SystemJTW · Traditional | Sierra Diagnostic, LLC | 02/28/2002SE |
| K993161 | Copan Easy-Swab Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 11/09/1999SE |
| K983244 | Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem)JTW · Traditional | Trek Diagnostic Systems, Inc. | 11/30/1998SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | Difco Laboratories, Inc. | 04/26/1996SE |
| K934894 | Cultureswab Transport SystemJTW · Traditional | Difco Laboratories, Inc. | 02/22/1994SE |
| K904773 | P and T MediumJTW · Traditional | Gibson Laboratories, Inc. | 12/04/1990SE |
| K895187 | FDL, Inc.'s Transport SystemJTW · Traditional | Fairleigh Dickinson Laboratories, Inc. | 10/24/1989SE |
| K882580 | Mechanical Change in In-Vitro Micro DeviceJTW · Traditional | Precision Dynamics Corp. | 07/08/1988SE |
More from Precision Dynamics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K946286 | Copan Venturi Transystem Cary-Blair MediumJSM · 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 Liquid Amies Elution Swab (Eswab) Collection and Transport System cleared by the FDA?
Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System (K061301) received a 510(k) decision of Substantially Equivalent on June 23, 2006, 44 days after the submission was received.
What is the product code of K061301?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.