K131630 is an FDA 510(k) clearance for the PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM. This device is classified as a Device, Specimen Collection (Class I - General Controls, product code LIO).
Submitted by Puritan Medical Products, LLC (Guilford, US). The FDA issued a Cleared decision on October 21, 2013, 139 days after receiving the submission on June 4, 2013.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K131630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2013 |
| Decision Date | October 21, 2013 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LIO - Device, Specimen Collection |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |