FDA 510(k) Applications Submitted by ARK DIAGNOSTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K180427 02/16/2018 ARK Fentanyl Assay ARK Diagnostics, Inc.
K182280 08/22/2018 ARK Tramadol Assay ARK Diagnostics, Inc.
K182779 10/01/2018 ARK EDDP Assay ARK Diagnostics, Inc.
K163359 11/30/2016 ARK Methotrexate Assay ARK Diagnostics, Inc.
K153596 12/16/2015 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control ARK DIAGNOSTICS, INC.
K200197 01/27/2020 ARK Fentanyl II Assay ARK Diagnostics, Inc.
K201089 04/23/2020 ARK Lacosamide Assay ARK Diagnostics, Inc.


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