IRISPEC URINE CHEMISTRY CONTROL PART A AND B

IRISPEC URINE CHEMISTRY CONTROL PART A AND B is an FDA 510(k)-cleared medical device (K945913) manufactured by International Remote Imaging Systems. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 4, 1995. Regulation: 8.