
Sigma Chemical Co.
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HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA is an FDA 510(k)-cleared medical device (K861049) manufactured by Sigma Chemical 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 28, 1986. Regulation: 8.