K142094 is an FDA 510(k) clearance for the COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Copan Italia Spa (Marlborough, US). The FDA issued a Cleared decision on April 10, 2015, 252 days after receiving the submission on August 1, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K142094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2014 |
| Decision Date | April 10, 2015 |
| Days to Decision | 252 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 |