TINTELIZE PAI-1 KIT

TINTELIZE PAI-1 KIT is an FDA 510(k)-cleared medical device (K960438) manufactured by Medical Diagnostic Technologies, 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 4, 1996. Regulation: 8.