510(k) K161220 · OCC Respiratory Virus Panel Nucleic Acid Assay System
ARIES® Flu A/B & RSV Assay
| Applicant | Luminex Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Aug 2, 2016 |
| Received | Apr 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161220
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Luminex Corporation ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 Open, Classified |
OZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.