ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS

ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS is an FDA 510(k)-cleared medical device (K082340) manufactured by Roche Diagnostics Corp.. 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 June 18, 2009. Regulation: 8.