PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS

PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS is an FDA 510(k)-cleared medical device (K832708) manufactured by American Dade. 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 13, 1983. Regulation: 8.