Oryum and Ovem Epidermal Deri Prick Test Applicator

Oryum and Ovem Epidermal Deri Prick Test Applicator is an FDA 510(k)-cleared medical device (K182582) manufactured by Allergy & Applicator Depot, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2019. Regulation: 8.