510(k) K062966 ยท ORH Lamotrigine Assay
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 12, 2007 |
| Received | Sep 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062966
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.