ARK Fentanyl Assay— 510(k) K180427

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K180427 for ARK Fentanyl Assay, Substantially Equivalent on 2018-06-06. Applicant: Ark Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2018-02-16
Decision date: 2018-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.