INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC is an FDA 510(k)-cleared medical device (K990992) manufactured by Roche Diagnostics Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 1999. Regulation: 8.