K182391 is an FDA 510(k) clearance for the ASI Automated ASI RPR Test for Syphilis on 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 November 30, 2018, 87 days after receiving the submission on September 4, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3820.
| 510(k) Number | K182391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2018 |
| Decision Date | November 30, 2018 |
| Days to Decision | 87 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 |