510(k) K060773 ยท LAR Enzyme Immunoassay, Procainamide
ONLINE TDM PROCAINAMIDE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 23, 2006 |
| Received | Mar 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060773
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.