ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET

ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET is an FDA 510(k)-cleared medical device (K052982) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2005. Regulation: 8.