The following data is part of a premarket notification filed by Copan Diagnostics, Inc. with the FDA for Copan Venturi Transystem Liquid Stuarts Medium.
| Device ID | K946283 |
| 510k Number | K946283 |
| Device Name: | COPAN VENTURI TRANSYSTEM LIQUID 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489696967 | K946283 | 000 |
| 38053326000905 | K946283 | 000 |
| 58053326002040 | K946283 | 000 |
| 58053326008943 | K946283 | 000 |
| 38053326001520 | K946283 | 000 |
| 58053326001883 | K946283 | 000 |
| 58053326001975 | K946283 | 000 |
| 58053326001982 | K946283 | 000 |
| 58053326001999 | K946283 | 000 |
| 58053326002002 | K946283 | 000 |
| 58053326002057 | K946283 | 000 |
| 58053326002125 | K946283 | 000 |
| 58053326002132 | K946283 | 000 |
| 58053326008776 | K946283 | 000 |
| 58053326008820 | K946283 | 000 |
| 58053326008844 | K946283 | 000 |
| 58053326008868 | K946283 | 000 |
| 38053326000882 | K946283 | 000 |