510(k) K243396 ยท QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Aptima SARS-CoV-2 Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 13, 2025 |
| Received | Oct 31, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243396
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.