
Instrumentation Laboratory (IL) Co.
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HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL is an FDA 510(k)-cleared medical device (K251968) manufactured by Instrumentation Laboratory (IL) 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 July 23, 2025. Regulation: 8.