ARK Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
ARK Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ARK Levetiracetam II Assay, ARK Methotrexate II Assay, ARK Hydrocodone Assay
17
Total
16
Cleared
1
Denied
ARK Diagnostics, Inc. has 16 FDA 510(k) cleared toxicology devices. Based in Sunnyvale, US.
Latest FDA clearance: Feb 2024. Active since 2009.
Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - ARK Diagnostics, Inc.
17 devices
Cleared
Feb 27, 2024
ARK Levetiracetam II Assay
Toxicology
193d
Cleared
Dec 20, 2023
ARK Methotrexate II Assay
Toxicology
166d
Cleared
Nov 09, 2023
ARK Hydrocodone Assay
Chemistry
147d
Cleared
Aug 05, 2021
ARK Lacosamide Assay
Toxicology
469d
Cleared
Feb 26, 2020
ARK Fentanyl II Assay
Toxicology
30d
Cleared
Dec 10, 2018
ARK Tramadol Assay
Toxicology
110d
Cleared
Nov 21, 2018
ARK EDDP Assay
Toxicology
51d
Cleared
Jun 06, 2018
ARK Fentanyl Assay
Toxicology
110d
Cleared
Aug 18, 2017
ARK Methotrexate Assay
Toxicology
261d
Not Cleared
May 05, 2017
ARK Voriconazole II Assay Test System
Toxicology
294d
Cleared
Aug 09, 2016
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator,...
Toxicology
237d
Cleared
Oct 18, 2011
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE...
Toxicology
105d