PRESAGE ST2 ASSAY

PRESAGE ST2 ASSAY is an FDA 510(k)-cleared medical device (K111452) manufactured by Critical Care Diagnostics, Inc. (Dba Critical Diag. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2011. Regulation: 8.