ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)

ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) is an FDA 510(k)-cleared medical device (K861231) manufactured by Hi Chem, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 27, 1986. Regulation: 8.