510(k) K897072 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 29, 1990 |
| Received | Dec 22, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897072
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.