ARK™ Fentanyl II Assay

Enzyme Immunoassay, Opiates

ARK Diagnostics, Inc.

The following data is part of a premarket notification filed by Ark Diagnostics, Inc. with the FDA for Ark™ Fentanyl Ii Assay.

Pre-market Notification Details

Device IDK200197
510k NumberK200197
Device Name:ARK™ Fentanyl II Assay
ClassificationEnzyme Immunoassay, Opiates
Applicant ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont,  CA  94538
ContactThomas Houts
CorrespondentThomas Houts
ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont,  CA  94538
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyToxicology
510k Review PanelToxicology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-27
Decision Date2020-02-26

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.