510(k) K993473

SYNCHRON SYSTEMS DRUG CALIBRATOR 2 by Beckman Coulter, Inc. — Product Code DLJ

K993473 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS DRUG CALIBRATOR 2". The FDA issued a decision of Substantially Equivalent on November 26, 1999. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.