LYME STAT TEST KIT

LYME STAT TEST KIT is an FDA 510(k)-cleared medical device (K875286) manufactured by Whittaker Bioproducts, 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 March 29, 1988. Regulation: 8.