510(k) K041658

BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 by Bio-Rad Laboratories, Inc. — Product Code LKJ

K041658 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200". The FDA issued a decision of Substantially Equivalent on December 20, 2004. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.