
Instrumentation Laboratory CO
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ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) is an FDA 510(k)-cleared medical device (K073377) 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 May 3, 2008. Regulation: 8.