RAPIDPOINT 405 NEONATAL BILIRUBIN

RAPIDPOINT 405 NEONATAL BILIRUBIN is an FDA 510(k)-cleared medical device (K110277) 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 August 14, 2011. Regulation: 8.