HemosIL CL HIT-IgG(PF4-H)

HemosIL CL HIT-IgG(PF4-H) is an FDA 510(k)-cleared medical device (K243374) 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 January 27, 2025. Regulation: 8.