510(k) K060586 ยท LEH Radioimmunoassay, Vancomycin
ENZYME IMMUNOASSAY, VANCOMYCIN
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 11, 2006 |
| Received | Mar 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2016 | Roche Diagnostics Operations, Inc. ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P)
The ONLINE TDM Vancomycin assay is for the quantitative determination Terminated |
LEH | None listed |
| Jun 9, 2007 | Roche Diagnostics Corp. Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190. Terminated |
LEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.