510(k) K161158 ยท CEW Radioimmunoassay, Parathyroid Hormone
IDS-iSYS Intact PTHN
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, GB |
| Decision | Substantially Equivalent, Jan 31, 2017 |
| Received | Apr 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161158
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.