ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS

ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS is an FDA 510(k)-cleared medical device (K930796) manufactured by Alko Diagnostic Corp.. This device is classified under the Immunology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 12, 1994. Regulation: 8.