510(k) K243485 ยท PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Alinity m CMV
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Jul 1, 2025 |
| Received | Nov 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243485
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.