ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control— 510(k) K153596

Name: FDA 510(k) clearance K153596
Creator: U.S. Food and Drug Administration
Published: 2016-08-09

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K153596 for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control, Substantially Equivalent on 2016-08-09. Applicant: Ark Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code POX
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 2015-12-16
Decision date: 2016-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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