K173376 is an FDA 510(k) clearance for the ASI Evolution. This device is classified as a Antigens, Nontreponemal, All (Class II - Special Controls, product code GMQ).
Submitted by Arlington Scientific, Inc. (Asi) (Springville, US). The FDA issued a Cleared decision on June 14, 2018, 227 days after receiving the submission on October 30, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3820.
| 510(k) Number | K173376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2017 |
| Decision Date | June 14, 2018 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GMQ - Antigens, Nontreponemal, All |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3820 |