510(k) K181436 ยท KTN System, Test, Infectious Mononucleosis
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
| Applicant | SEKISUI Diagnostics, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 22, 2018 |
| Received | Jun 1, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181436
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.