510(k) K061794 ยท JZO System, Test, Thyroid Autoantibody
FIDIS TM THYRO, MODEL MX002
| Applicant | Biomedical Diagnostics (Bmd) SA, Marne La Vallee Cedex 2, FR |
| Decision | Substantially Equivalent, Nov 21, 2006 |
| Received | Jun 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061794
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.