510(k) K030428 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
ROCHE ONLINE TDM PHENYTOIN
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 28, 2003 |
| Received | Feb 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030428
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Roche Diagnostics Corp. Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190. Terminated |
DIP | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03516989190. Terminated |
DIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.