AMERLITE TBG ASSAY

AMERLITE TBG ASSAY is an FDA 510(k)-cleared medical device (K952284) manufactured by Johnson & Johnson Clinical Diagnostics, Inc.. 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 July 25, 1995. Regulation: 8.