STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY

STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K912241) manufactured by Baxter Healthcare Corp. 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 June 19, 1991. Regulation: 8.