ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY

ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY is an FDA 510(k)-cleared medical device (K981342) manufactured by Abbott Laboratories. 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 28, 1998. Regulation: 8.