REVISED LABELING FOR SYVA OPIATE ASSAYS

REVISED LABELING FOR SYVA OPIATE ASSAYS is an FDA 510(k)-cleared medical device (K873898) 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 October 28, 1987. Regulation: 8.