510(k) K111938 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, Tyne & Wear, GB |
| Decision | Substantially Equivalent, Feb 14, 2012 |
| Received | Jul 8, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K111938
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.