LYME-CHECK(TM) TEST KIT

LYME-CHECK(TM) TEST KIT is an FDA 510(k)-cleared medical device (K896378) manufactured by Diagnostic Technology, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 1991. Regulation: 8.