ELEGANCE NEONATAL TSH ELISA

ELEGANCE NEONATAL TSH ELISA is an FDA 510(k)-cleared medical device (K935049) manufactured by Bioclone Australia Pty , Ltd.. 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 October 2, 1994. Regulation: 8.