K222613 is an FDA 510(k) clearance for the ARX Liquid Amies Collection & Transport System. This device is classified as a Device, Specimen Collection (Class I - General Controls, product code LIO).
Submitted by Arx Sciences, Inc. (Amherst, US). The FDA issued a Cleared decision on March 27, 2024, 575 days after receiving the submission on August 30, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K222613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2022 |
| Decision Date | March 27, 2024 |
| Days to Decision | 575 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 |