ARK Lacosamide Assay— 510(k) K201089

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K201089 for ARK Lacosamide Assay, Substantially Equivalent on 2021-08-05. Applicant: Ark Diagnostics, Inc..

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code NWM
Advisory panel: Clinical Toxicology
Date received: 2020-04-23
Decision date: 2021-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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