510(k) K151799 ยท JZO System, Test, Thyroid Autoantibody
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Mar 25, 2016 |
| Received | Jul 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151799
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.