HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)

HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) is an FDA 510(k)-cleared medical device (K902155) manufactured by Hichem Diagnostics. 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 11, 1990. Regulation: 8.