IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS

IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS is an FDA 510(k)-cleared medical device (K864409) manufactured by Sclavo, Inc.. 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 December 21, 1986. Regulation: 8.