K946284 is an FDA 510(k) clearance for the COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Copan Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on March 10, 1995, 73 days after receiving the submission on December 27, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K946284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1994 |
| Decision Date | March 10, 1995 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JSM — Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |