510(k) K162840 ยท MRG System, Test, Vitamin D
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 8, 2017 |
| Received | Oct 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162840
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2018 | Roche Diagnostics Corporation Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190
Product Usage:
This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and Terminated |
MRG | None listed |
| Apr 27, 2018 | Roche Diagnostics Corporation Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160
Product Usage:
This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and Terminated |
MRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.