NEONATAL NTSH RADIOIMMUNOASSAY SYS

NEONATAL NTSH RADIOIMMUNOASSAY SYS is an FDA 510(k)-cleared medical device (K830036) manufactured by Corning Medical & Scientific. 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 January 27, 1983. Regulation: 8.