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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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