510(k) K053426 ยท JZO System, Test, Thyroid Autoantibody
ROCHE ELECSYS ANTI-TG
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 7, 2006 |
| Received | Dec 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053426
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.