510(k) K083391 ยท JZO System, Test, Thyroid Autoantibody
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
| Applicant | Diagnostic Hybrids, Inc., Athens OH, US |
| Decision | Substantially Equivalent, May 21, 2009 |
| Received | Nov 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083391
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.