DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO

DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO is an FDA 510(k)-cleared medical device (K884901) manufactured by Baxter Healthcare 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 February 1, 1989. Regulation: 8.