MACRA LP(A) ENZYME IMMUNOASSAY KIT

MACRA LP(A) ENZYME IMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K992665) manufactured by Trinity Biotech USA. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 1999. Regulation: 8.