HICHEM ISE STANDARDS KIT 70011

HICHEM ISE STANDARDS KIT 70011 is an FDA 510(k)-cleared medical device (K953863) 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 September 5, 1995. Regulation: 8.