510(k) K223093 ยท MID System, Test, Anticardiolipin Immunological
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 17, 2024 |
| Received | Sep 30, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223093
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.