BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT

BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT is an FDA 510(k)-cleared medical device (K861499) manufactured by Biostar Medical Products, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 1986. Regulation: 8.