STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY

STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K873052) manufactured by American Dade. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 13, 1987. Regulation: 8.