GEM Premier 7000 with IQM3

GEM Premier 7000 with IQM3 is an FDA 510(k)-cleared medical device (K223608) manufactured by Instrumentation Laboratory Company. 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 9, 2023. Regulation: 8.