The following data is part of a premarket notification filed by Copan Diagnostics, Inc. with the FDA for Copan Easy-swab Collection And Transport System.
| Device ID | K993161 |
| 510k Number | K993161 |
| Device Name: | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM |
| Classification | System, Transport, Aerobic |
| Applicant | COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane 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 | 1999-09-22 |
| Decision Date | 1999-11-09 |
| Summary: | summary |