HEMOLAB PROTEIN C CHROMOGENIC ASSAY

HEMOLAB PROTEIN C CHROMOGENIC ASSAY is an FDA 510(k)-cleared medical device (K934210) manufactured by Biomerieux Vitek, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 1994. Regulation: 8.