510(k) K143324 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IDS-iSYS CTX-I Calibration Verifiers
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, Tyne & Wear, GB |
| Decision | Substantially Equivalent, Mar 30, 2015 |
| Received | Nov 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143324
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.