NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT

NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT is an FDA 510(k)-cleared medical device (K021541) manufactured by Perkinelmer Life Sciences. 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 27, 2002. Regulation: 8.