ARK Diagnostics, Inc. - FDA 510(k) Cleared Devices
17
Total
16
Cleared
1
Denied
FDA 510(k) cleared devices by ARK Diagnostics, Inc. Toxicology ✕
16 devices
Cleared
Feb 27, 2024
ARK Levetiracetam II Assay
Toxicology
193d
Cleared
Dec 20, 2023
ARK Methotrexate II Assay
Toxicology
166d
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
Cleared
Nov 23, 2010
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL...
Toxicology
169d
Cleared
Oct 29, 2010
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
Toxicology
172d
Cleared
Dec 09, 2009
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO,...
Toxicology
168d
Cleared
Nov 02, 2009
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM...
Toxicology
146d
Cleared
Apr 16, 2009
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL,...
Toxicology
115d