510(k) K033603

INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 by Beckman Coulter, Inc. — Product Code LIG

K033603 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999". The FDA issued a decision of Substantially Equivalent on December 19, 2003. The device falls under product code LIG (Radioassay, Intrinsic Factor Blocking Antibody), a Class II device regulated under 21 CFR 862.1810. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.