510(k) K140554 ยท MRG System, Test, Vitamin D
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, Tyne & Wear, GB |
| Decision | Substantially Equivalent, Dec 19, 2014 |
| Received | Mar 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140554
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.