
Beckman Coulter, Inc.
Free shipping on orders over $99 · 30-day returns
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 is an FDA 510(k)-cleared medical device (K981985) manufactured by Beckman Coulter, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 1998. Regulation: 8.