510(k) K060690 ยท LEG Enzyme Immunoassay, Valproic Acid
ONLINE VALPROIC ACID
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 8, 2006 |
| Received | Mar 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060690
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2007 | Roche Diagnostics Corp. Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190. Terminated |
LEG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.