510(k) K222736 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 16, 2023 |
| Received | Sep 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2024 | Hologic, Inc. Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 Open, Classified |
QOF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.