510(k) K201438 ยท GMQ Antigens, Nontreponemal, All
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
| Applicant | Arlington Scientific, Inc. (Asi), Springville UT, US |
| Decision | Substantially Equivalent, Oct 21, 2020 |
| Received | Jun 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201438
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.