510(k) K142994 ยท CJM Radioimmunoassay, Aldosterone
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, Tyne & Wear, GB |
| Decision | Substantially Equivalent, Apr 21, 2015 |
| Received | Oct 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142994
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.