PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE is an FDA 510(k)-cleared medical device (K020129) manufactured by Phoenix Diagnostics, 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 January 31, 2002. Regulation: 8.