ENZYMATIC THEOPHYLLINE REAGENT, #500-82

ENZYMATIC THEOPHYLLINE REAGENT, #500-82 is an FDA 510(k)-cleared medical device (K901510) manufactured by Diagnostic Chemicals, Ltd. (Usa). 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 June 11, 1990. Regulation: 8.