STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO

STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO is an FDA 510(k)-cleared medical device (K912852) 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 September 26, 1991. Regulation: 8.