BILICHEK NON-INVASIVE BILIRUBIN ANALYZER

BILICHEK NON-INVASIVE BILIRUBIN ANALYZER is an FDA 510(k)-cleared medical device (K994438) manufactured by Spectrx, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 3, 2000. Regulation: 8.