510(k) K051211 ยท NWM Immunoassay, Anti-Seizure Drug
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 18, 2005 |
| Received | May 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051211
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.