DADE(R) PROTEIN C ABNORMAL CONTRAL

DADE(R) PROTEIN C ABNORMAL CONTRAL is an FDA 510(k)-cleared medical device (K911885) 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 June 10, 1991. Regulation: 8.