SPIFE IFE CALIBRATOR AND CONTROL KIT

SPIFE IFE CALIBRATOR AND CONTROL KIT is an FDA 510(k)-cleared medical device (K010617) manufactured by Helena Laboratories. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2001. Regulation: 8.