510(k) K250249 ยท GMQ Antigens, Nontreponemal, All
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
| Applicant | Gold Standard Diagnostics, LLC, Davis CA, US |
| Decision | Substantially Equivalent, Oct 10, 2025 |
| Received | Jan 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250249
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.