510(k) K926393 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
VIDAS THYROXINE (T4) ASSAY (T4)
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, May 13, 1993 |
| Received | Dec 21, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K926393
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.