510(k) K950588 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
T4 MICROWELL EIA (ENZYME IMMUNOASSAY0
| Applicant | Biomerica, Inc., Newport Beach CA, US |
| Decision | Substantially Equivalent, Jun 29, 1995 |
| Received | Feb 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950588
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.