REAGENTS & STANDARDS IL 501 NA/K

REAGENTS & STANDARDS IL 501 NA/K is an FDA 510(k)-cleared medical device (K840557) manufactured by Shaban Mfg. Co.. 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 April 3, 1984. Regulation: 8.