510(k) K243935 ยท PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Aptima CMV Quant Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 17, 2025 |
| Received | Dec 20, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243935
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.