510(k) K060853 ยท KLB Radioimmunoassay, Tobramycin
ONLINE TDM TOBRAMYCIN
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 9, 2006 |
| Received | Mar 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060853
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2007 | Roche Diagnostics Corp. Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190. (Note: Not distributed within the United States) Terminated |
KLB | None listed |
| Jun 9, 2007 | Roche Diagnostics Corp. Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.) Terminated |
KLB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.