ACE T4 REAGENT T4 CALIBRATORS

ACE T4 REAGENT T4 CALIBRATORS is an FDA 510(k)-cleared medical device (K981377) manufactured by Schiapparelli Biosystems, Inc.. 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 9, 1998. Regulation: 8.