510(k) K090588

POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 by Beckman Coulter, Inc. — Product Code CDD

K090588 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210". The FDA issued a decision of Substantially Equivalent on May 27, 2009. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.