OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY

OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY is an FDA 510(k)-cleared medical device (K980178) manufactured by Bionostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 11, 1998. Regulation: 8.