510(k) K171641 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Accula Flu A/Flu B Test
| Applicant | Mesa Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 6, 2018 |
| Received | Jun 2, 2017 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K171641
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.