FIAX TEST KIT FOR THEOPHYLLINE QUANT.

FIAX TEST KIT FOR THEOPHYLLINE QUANT. is an FDA 510(k)-cleared medical device (K801642) manufactured by Intl. Diagnostic Technology. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 1980. Regulation: 8.