TOUCH TEAR IGE MICROASSAY KIT

TOUCH TEAR IGE MICROASSAY KIT is an FDA 510(k)-cleared medical device (K991316) manufactured by Touch Scientific, 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 August 8, 1999. Regulation: 8.