ROCHE AMMONIA (VARIOUS)

ROCHE AMMONIA (VARIOUS) is an FDA 510(k)-cleared medical device (K942048) manufactured by Roche Diagnostic Systems, Inc.. 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 3, 1994. Regulation: 8.