EXL ANEM CAL, MODEL RC640

EXL ANEM CAL, MODEL RC640 is an FDA 510(k)-cleared medical device (K093645) 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 March 4, 2010. Regulation: 8.