The following data is part of a premarket notification filed by Copan Diagnostics, Inc. with the FDA for Copan Viral Transystem.
| Device ID | K001780 |
| 510k Number | K001780 |
| Device Name: | COPAN VIRAL TRANSYSTEM |
| Classification | Culture Media, Non-propagating Transport |
| 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 | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-13 |
| Decision Date | 2001-07-31 |