E. HISTOLYTICA QUIK CHEK

E. HISTOLYTICA QUIK CHEK is an FDA 510(k)-cleared medical device (K170728) manufactured by Techlab, 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 June 6, 2017. Regulation: 8.