
Innotron of Oregon, Inc.
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INNOTRON INNOFLUOR PHEYTOIN REAGENT SET is an FDA 510(k)-cleared medical device (K872563) manufactured by Innotron of Oregon, 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 August 20, 1987. Regulation: 8.