Panels › Clinical Toxicology › Product code KLB · Class 2
Radioimmunoassay, Tobramycin
Regulation 862.3900
0510(k)s in 12 months (23 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KLB
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Products Corp. | 3 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 0 |
| Roche Diagnostics Corp. | 1 | 2 |
| Bio-Rad | 2 | 0 |
| Syva Co. | 2 | 0 |
| Alpha Gamma Laboratory | 1 | 0 |
| Antibodies, Inc. | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Biosan Laboratories, Inc. | 1 | 0 |
| Clinical Assays, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K060853 |
| 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 | K060853 |
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