510(k) K020704 ยท LCD Enzyme Immunoassay, Gentamicin
ROCHE ONLINE GENTAMICIN
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 12, 2002 |
| Received | Mar 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2010 | Roche Diagnostics Operations, Inc. Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190.
The product is used for in vitro diagnostic reagent for the quantitative dete Terminated |
LCD | None listed |
| Mar 8, 2010 | Roche Diagnostics Operations, Inc. Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190.
The product is used for in vitro diagnostic reagent for the quantitative determination Terminated |
LCD | None listed |
| Mar 8, 2010 | Roche Diagnostics Operations, Inc. Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190.
The product is used for in vitro diagnostic reagent for the quantitative determination of g Terminated |
LCD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.