HEMOGLOBIN A2 MICRO COLUMN TEST

HEMOGLOBIN A2 MICRO COLUMN TEST is an FDA 510(k)-cleared medical device (K896168) manufactured by Bio-Rad. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 17, 1990. Regulation: 8.