
Coulter Corp.
Free shipping on orders over $99 · 30-day returns
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES is an FDA 510(k)-cleared medical device (K993356) manufactured by Coulter Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 2000. Regulation: 8.