ARK Tramadol Assay— 510(k) K182280

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K182280 for ARK Tramadol Assay, Substantially Equivalent on 2018-12-10. 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: 2018-08-22
Decision date: 2018-12-10
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.