EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 is an FDA 510(k)-cleared medical device (K011347) 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 May 16, 2001. Regulation: 8.