510(k) K171963 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 26, 2017 |
| Received | Jun 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171963
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Hologic, Inc Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium H Open, Classified |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.