
Schiapparelli Biosystems, Inc.
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ACE(TM) CEDIA(R) PHENYTOIN ASSAY is an FDA 510(k)-cleared medical device (K944085) manufactured by Schiapparelli Biosystems, 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 December 27, 1994. Regulation: 8.