510(k) K231017 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Panther Fusion AdV/hMPV/RV Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 5, 2023 |
| Received | Apr 10, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231017
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.