510(k) K181473 ยท QCU Dengue Virus Antigen Assay
DENV Detect NS1 ELISA
| Applicant | InBios International, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Aug 27, 2018 |
| Received | Jun 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181473
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.