510(k) K063520 ยท OAV Mycophenolic Acid Test System
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 16, 2007 |
| Received | Nov 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063520
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.