DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE

DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE is an FDA 510(k)-cleared medical device (K081300) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 1, 2008. Regulation: 8.