
Instrumentation Laboratory CO
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IL TEST (TM) PT-FIBRINOGEN HS PLUS is an FDA 510(k)-cleared medical device (K933252) 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 October 3, 1993. Regulation: 8.