CHROMOLIZE TPA ASSAY KIT

CHROMOLIZE TPA ASSAY KIT is an FDA 510(k)-cleared medical device (K962489) 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 July 30, 1996. Regulation: 8.