ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 is an FDA 510(k)-cleared medical device (K062434) manufactured by Agamatrix. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 2006. Regulation: 8.