EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS

EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS is an FDA 510(k)-cleared medical device (K913429) manufactured by Syva Co.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 25, 1991. Regulation: 8.