K121039 is an FDA 510(k) clearance for the COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM. This device is classified as a System, Transport, Aerobic (Class I - General Controls, product code JTW).
Submitted by Copan Flock Technologies (North Attleboro, US). The FDA issued a Cleared decision on May 25, 2012, 50 days after receiving the submission on April 5, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K121039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2012 |
| Decision Date | May 25, 2012 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JTW — System, Transport, Aerobic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |