510(k) K031856 ยท DKB Calibrators, Drug Mixture
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 6, 2003 |
| Received | Jun 16, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031856
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190.
Calibrator designed for the calibration of Roche assays for the quantitative determination of certain dr Terminated |
DKB | None listed |
| Sep 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190.
Calibrator designed for the calibration of Roche assays for the quantitative determination of certain d Terminated |
DKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.