ELECSYS N-MID OSTEOCALCIN CALCHECK 5

ELECSYS N-MID OSTEOCALCIN CALCHECK 5 is an FDA 510(k)-cleared medical device (K112104) 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 August 24, 2011. Regulation: 8.