510(k) K190204 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
ID NOW Influenza A & B 2
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Mar 18, 2019 |
| Received | Feb 4, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190204
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.