ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS

ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS is an FDA 510(k)-cleared medical device (K884267) manufactured by Alko Diagnostic Corp.. 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 May 3, 1989. Regulation: 8.