NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 is an FDA 510(k)-cleared medical device (DEN040002) manufactured by Perkinelmer Life Sciences, 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 August 23, 2004. Regulation: 8.