510(k) K243979 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Aptiva APS IgA Reagent
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 6, 2026 |
| Received | Dec 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243979
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.