510(k) K243496 ยท NOM Antigen, Galactomannan, Aspergillus Spp.
MycoMEIA Aspergillus Assay
| Applicant | Pearl Diagnostics, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Aug 1, 2025 |
| Received | Nov 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243496
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.