IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM

IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM is an FDA 510(k)-cleared medical device (K911060) manufactured by Immunomatrix. 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 May 7, 1991. Regulation: 8.