UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311

UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 is an FDA 510(k)-cleared medical device (K922770) manufactured by Leica, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 17, 1992. Regulation: 8.