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FDA 510(k)

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

K-Number: K153596 · 2016-08-09

ApplicantArk Diagnostics, Inc.
Decision Date2016-08-09
Product CodePOX
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-08-09 under approval number K153596. The device is classified under product code POX. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is a medical device that received FDA 510(k) clearance on 2016-08-09. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K153596.

When was ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control approved by the FDA?

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control received FDA 510(k) clearance on 2016-08-09, under approval number K153596.

What company makes ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is manufactured by Ark Diagnostics, Inc..

What is the FDA product code for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

The FDA product code for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is POX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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