ELECTROLYTE STANDARD - CORNING NALK ISE

ELECTROLYTE STANDARD - CORNING NALK ISE is an FDA 510(k)-cleared medical device (K830589) manufactured by Shaban Mfg. Co.. 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 April 26, 1983. Regulation: 8.