GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)

GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) is an FDA 510(k)-cleared medical device (K861893) manufactured by Hi Chem, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 1986. Regulation: 8.