510(k) K874866 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
| Applicant | Serono Diagnostics, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Feb 11, 1988 |
| Received | Nov 27, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874866
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.