510(k) K982935

SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR by Beckman Coulter, Inc. — Product Code KXT

K982935 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR". The FDA issued a decision of Substantially Equivalent on October 14, 1998. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.