
Syva Co.
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EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 is an FDA 510(k)-cleared medical device (K011528) 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 June 5, 2001. Regulation: 8.