K162284 is an FDA 510(k) clearance for the Puritan Fecal Opti-Swab Collection and Transport System. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Puritan Medical Products, LLC (Guilford, US). The FDA issued a Cleared decision on November 4, 2016, 81 days after receiving the submission on August 15, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K162284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2016 |
| Decision Date | November 04, 2016 |
| Days to Decision | 81 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 |