
Analytical Control Systems, Inc.
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ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I is an FDA 510(k)-cleared medical device (K893784) manufactured by Analytical Control Systems, 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 June 22, 1989. Regulation: 8.