510(k) K911217 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
| Applicant | Serono-Baker Diagnostics, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | Mar 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911217
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.