510(k) K111650 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, Tyne & Wear, GB |
| Decision | Substantially Equivalent, Sep 6, 2011 |
| Received | Jun 13, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K111650
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.