The following data is part of a premarket notification filed by Copan Diagnostics, Inc. with the FDA for Copan Venturi Transystem Liquid Amies Medium.
| Device ID | K946288 |
| 510k Number | K946288 |
| Device Name: | COPAN VENTURI TRANSYSTEM LIQUID AMIES 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 |
|---|---|---|
| 58053326009957 | K946288 | 000 |
| 58053326002026 | K946288 | 000 |
| 38053326001551 | K946288 | 000 |
| 38053326001568 | K946288 | 000 |
| 58053326001876 | K946288 | 000 |
| 58053326001937 | K946288 | 000 |
| 58053326001944 | K946288 | 000 |
| 58053326001951 | K946288 | 000 |
| 58053326001968 | K946288 | 000 |
| 58053326002033 | K946288 | 000 |
| 58053326002101 | K946288 | 000 |
| 58053326002118 | K946288 | 000 |
| 58053326005355 | K946288 | 000 |
| 58053326008813 | K946288 | 000 |
| 58053326008837 | K946288 | 000 |
| 58053326008851 | K946288 | 000 |
| 58053326008936 | K946288 | 000 |
| 58053326008950 | K946288 | 000 |
| 38053326000899 | K946288 | 000 |