510(k) K011465

SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO by Beckman Coulter, Inc. — Product Code LDP

K011465 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO". The FDA issued a decision of Substantially Equivalent on June 8, 2001. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.