QUANTICEL HHR # L500 AND L501

QUANTICEL HHR # L500 AND L501 is an FDA 510(k)-cleared medical device (K781786) manufactured by Bhp Diagnostix, 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 November 14, 1978. Regulation: 8.