The following data is part of a premarket notification filed by Copan Diagnostics, Inc. with the FDA for Copan Liquid Amies Elution Swab (eswab) Collection And Transport System.
| Device ID | K061301 |
| 510k Number | K061301 |
| Device Name: | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM |
| Classification | System, Transport, Aerobic |
| Applicant | COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia Sinclair |
| Correspondent | Cynthia Sinclair COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-10 |
| Decision Date | 2006-06-23 |
| Summary: | summary |