GSP NEONATAL IRT KIT (3306-001U)

GSP NEONATAL IRT KIT (3306-001U) is an FDA 510(k)-cleared medical device (K102419) manufactured by Wallac Oy, Subsidiary of Perkinelmer. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 15, 2010. Regulation: 8.