Copan Easy-Swab Collection and Transport System
FDA 510(k) K993161 · Copan Diagnostics, Inc.
510(k) numberK993161
Submission
- Device name
- Copan Easy-Swab Collection and Transport System
- Applicant
- Copan Diagnostics, Inc.
North Attleboro, MA, US - Received
- September 22, 1999
- Decision date
- November 9, 1999
- 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 |
| K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 06/23/2006SE |
| 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 |
| 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 |
|---|---|---|
| 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 |
| 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 Easy-Swab Collection and Transport System cleared by the FDA?
Copan Easy-Swab Collection and Transport System (K993161) received a 510(k) decision of Substantially Equivalent on November 9, 1999, 48 days after the submission was received.
What is the product code of K993161?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.