GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT is an FDA 510(k)-cleared medical device (K090846) manufactured by Perkinelmer, 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 September 2, 2009. Regulation: 8.