Aina HbA1c Monitoring System 2

Aina HbA1c Monitoring System 2 is an FDA 510(k)-cleared medical device (K192987) manufactured by Jana Care, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2020. Regulation: 8.