ARK Diagnostics, Inc.

ARK Diagnostics, Inc. — FDA 510(k) Submissions

ARK Diagnostics, Inc. has submitted 17 FDA 510(k) premarket notifications since 2009, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Immunoassay, Anti-seizure Drug, Enzyme Immunoassay, Methotrexate, Levetiracetam Assay, Voriconazole Test System . Use the specialty filter in the sidebar to narrow results.