AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE

AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE is an FDA 510(k)-cleared medical device (K951877) manufactured by Chimera Research & Chemical, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 13, 1996. Regulation: 8.