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Ark Diagnostics, Inc.
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ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 is an FDA 510(k)-cleared medical device (K091884) manufactured by Ark Diagnostics, 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 8, 2009. Regulation: 8.
