K972448 is an FDA 510(k) clearance for the COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL. This device is classified as a Culture Media, Anaerobic Transport (Class I - General Controls, product code JSL).
Submitted by Copan Italia Spa (North Attleboro, US). The FDA issued a Cleared decision on August 20, 1997, 51 days after receiving the submission on June 30, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K972448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1997 |
| Decision Date | August 20, 1997 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JSL — Culture Media, Anaerobic Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |