TPC-LYOPHILIZED POOLED HUMAN PLASMA

TPC-LYOPHILIZED POOLED HUMAN PLASMA is an FDA 510(k)-cleared medical device (K761091) manufactured by Bio/Data Corp.. 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 31, 1977. Regulation: 8.