ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK

ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK is an FDA 510(k)-cleared medical device (K053059) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 27, 2005. Regulation: 8.