PREMIER HB9210 HBA1C ANALYZER

PREMIER HB9210 HBA1C ANALYZER is an FDA 510(k)-cleared medical device (K112015) manufactured by Primus Corporation Dba Trinity Biotech. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2011. Regulation: 8.