510(k) K984163 ยท JZO System, Test, Thyroid Autoantibody
ANTI-TPO EIA DIAGNOSTIC TEST KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Feb 2, 1999 |
| Received | Nov 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984163
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.