510(k) K113546 ยท MRG System, Test, Vitamin D
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 24, 2012 |
| Received | Dec 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113546
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.