510(k) K161082 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, GB |
| Decision | Substantially Equivalent, May 17, 2016 |
| Received | Apr 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161082
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.