CLEARinse CTS Specimen Collection and Transport System

CLEARinse CTS Specimen Collection and Transport System is an FDA 510(k)-cleared medical device (K221664) manufactured by Aardvark Medical, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 2, 2023. Regulation: 8.