ASSESS(TM) LOW ABNORMAL CONTROL

ASSESS(TM) LOW ABNORMAL CONTROL is an FDA 510(k)-cleared medical device (K931117) manufactured by Instrumentation Laboratory CO. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 1994. Regulation: 8.