
Medical Laboratory Automation Systems, Inc.
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ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER is an FDA 510(k)-cleared medical device (K864534) 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 5, 1987. Regulation: 8.