ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER

ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER is an FDA 510(k)-cleared medical device (K944227) manufactured by Medical Laboratory Automation 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 February 2, 1995. Regulation: 8.