N-ACETYLPROCAINAMIDE ASSAY FOR COBAS

N-ACETYLPROCAINAMIDE ASSAY FOR COBAS is an FDA 510(k)-cleared medical device (K832098) 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 11, 1983. Regulation: 8.