510(k) K023764

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 by Beckman Coulter, Inc. — Product Code JJE

K023764 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100". The FDA issued a decision of Substantially Equivalent on January 28, 2003. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.