The following data is part of a premarket notification filed by Copan Diagnostics, Inc. with the FDA for Copan Venturi Transystem Stuarts Medium.
| Device ID | K946285 |
| 510k Number | K946285 |
| Device Name: | COPAN VENTURI TRANSYSTEM STUARTS MEDIUM |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | COPAN DIAGNOSTICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary M Mcnamara |
| Correspondent | Mary M Mcnamara 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 | 1994-12-27 |
| Decision Date | 1995-03-10 |