BD FACS SAMPLE PREP ASSISTANT III (SPA III)

BD FACS SAMPLE PREP ASSISTANT III (SPA III) is an FDA 510(k)-cleared medical device (K102064) manufactured by Becton, Dickinson & CO. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 6, 2011. Regulation: 8.