510(k) K061190

ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 by Beckman Coulter, Inc. — Product Code CEW

K061190 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953". The FDA issued a decision of Substantially Equivalent on September 15, 2006. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.