
Oxis Intl., Inc.
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INNOFLUOR PHENYTOIN ASSAY SYSTEM is an FDA 510(k)-cleared medical device (K955562) manufactured by Oxis Intl., 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 January 23, 1996. Regulation: 8.