510(k) K141341 ยท PIT Leishmania Spp. Antigen Detection Assay
CL DETECT RAPID TEST
| Applicant | InBios International, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Nov 14, 2014 |
| Received | May 21, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141341
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.