510(k) K182280— ARK Tramadol Assay

Substantially Equivalent

Ark Diagnostics, Inc.

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2018-08-22
Decision date: 2018-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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