510(k) K982298 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
OPTICOAT T4 EIA KIT
| Applicant | Biotecx Laboratories, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Feb 3, 1999 |
| Received | Jul 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982298
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.