Flowflex COVID-19 Antigen Home Test

Flowflex COVID-19 Antigen Home Test is an FDA 510(k)-cleared medical device (K230828) manufactured by ACON Laboratories, 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 November 8, 2023. Regulation: 8.