
American Bio-Science Laboratories
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AMER. BIO-SCIENCE LAB CORTISOL REAGENT is an FDA 510(k)-cleared medical device (K842455) manufactured by American Bio-Science Laboratories. 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 August 15, 1984. Regulation: 8.