COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA

COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA is an FDA 510(k)-cleared medical device (K925344) 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 January 20, 1993. Regulation: 8.