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FDA 510(k)

ARK Levetiracetam II Assay

K-Number: K232522 · 2024-02-27

ApplicantArk Diagnostics, Inc.
Decision Date2024-02-27
Product CodeORI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARK Levetiracetam II Assay is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-02-27 under approval number K232522. The device is classified under product code ORI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARK Levetiracetam II Assay?

ARK Levetiracetam II Assay is a medical device that received FDA 510(k) clearance on 2024-02-27. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K232522.

When was ARK Levetiracetam II Assay approved by the FDA?

ARK Levetiracetam II Assay received FDA 510(k) clearance on 2024-02-27, under approval number K232522.

What company makes ARK Levetiracetam II Assay?

ARK Levetiracetam II Assay is manufactured by Ark Diagnostics, Inc..

What is the FDA product code for ARK Levetiracetam II Assay?

The FDA product code for ARK Levetiracetam II Assay is ORI.

Other Devices by Ark Diagnostics, Inc.

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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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