510(k) K971709 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
TOTAL THROXINE MICROPLATE EIA(225-300)
| Applicant | Monobind, Costa Mesa CA, US |
| Decision | Substantially Equivalent, Jun 16, 1997 |
| Received | May 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971709
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.