510(k) K192719 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Osom Ultra Plus Flu A&B Test Kit
| Applicant | SEKISUI Diagnostics, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 3, 2020 |
| Received | Sep 26, 2019 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K192719
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.