510(k) K193167 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Dec 11, 2019 |
| Received | Nov 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193167
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2024 | Luminex Molecular Diagnostics Inc NxTAG Respiratory Pathogen Panel, REF: I051C0447 Open, Classified |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.