510(k) K080159 ยท JZO System, Test, Thyroid Autoantibody
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
| Applicant | Kronus Market Development Associates, Inc., Boise ID, US |
| Decision | Substantially Equivalent, May 22, 2008 |
| Received | Jan 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080159
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.