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. |
| K232522 |
08/18/2023 |
ARK Levetiracetam II 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. |
| K232017 |
07/07/2023 |
ARK Methotrexate II Assay |
ARK Diagnostics, Inc. |
| K231752 |
06/15/2023 |
ARK Hydrocodone Assay |
ARK Diagnostics, Inc. |
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