
Beckman Coulter, Inc.
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 is an FDA 510(k)-cleared medical device (K032287) manufactured by Beckman Coulter, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 2003. Regulation: 8.