LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL

LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL is an FDA 510(k)-cleared medical device (K911347) 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 June 9, 1991. Regulation: 8.