LYME STAT M TEST KIT

LYME STAT M TEST KIT is an FDA 510(k)-cleared medical device (K904652) 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 October 20, 1991. Regulation: 8.