510(k) K080092 ยท JZO System, Test, Thyroid Autoantibody
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 28, 2008 |
| Received | Jan 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080092
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.