510(k) K051211

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS by Seradyn, Inc. — Product Code NWM

K051211 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on November 18, 2005. The device falls under product code NWM (Immunoassay, Anti-Seizure Drug), a Class II device regulated under 21 CFR 862.3350. Seradyn, Inc. has at least 10 other 510(k) clearances on record.