3M IGG FASTLYME(TM) TEST

3M IGG FASTLYME(TM) TEST is an FDA 510(k)-cleared medical device (K895713) manufactured by 3M Company. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 1990. Regulation: 8.