510(k) K061382

ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 by Beckman Coulter, Inc. — Product Code JZO

K061382 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227". The FDA issued a decision of Substantially Equivalent on July 6, 2006. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.