OREIA II B-HCG, ENZYME INNUNOASSAY

OREIA II B-HCG, ENZYME INNUNOASSAY is an FDA 510(k)-cleared medical device (K832801) manufactured by Organon, 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 December 7, 1983. Regulation: 8.