LOCI 8 CALIBRATOR, MODEL KC 646

LOCI 8 CALIBRATOR, MODEL KC 646 is an FDA 510(k)-cleared medical device (K101460) manufactured by Siemens Healthcare 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 July 8, 2010. Regulation: 8.