510(k) K182391 ยท GMQ Antigens, Nontreponemal, All
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
| Applicant | Arlington Scientific, Inc. (Asi), Springville UT, US |
| Decision | Substantially Equivalent, Nov 30, 2018 |
| Received | Sep 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182391
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.