510(k) K060738 ยท LAN Enzyme Immunoassay, N-Acetylprocainamide
TDM N-ACETYLPROCAINAMIDE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 16, 2006 |
| Received | Mar 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2010 | Roche Diagnostics Operations, Inc. ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN. Terminated |
LAN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.