510(k) K191514 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
CareStart Flu A&B Plus
| Applicant | Access Bio, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, Feb 18, 2020 |
| Received | Jun 7, 2019 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K191514
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.