
Haemachem, Inc.
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HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY is an FDA 510(k)-cleared medical device (K853239) manufactured by Haemachem, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 1985. Regulation: 8.