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FDA 510(k)

ARK Tramadol Assay

K-Number: K182280 · 2018-12-10

ApplicantArk Diagnostics, Inc.
Decision Date2018-12-10
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARK Tramadol Assay is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-12-10 under approval number K182280. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARK Tramadol Assay?

ARK Tramadol Assay is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K182280.

When was ARK Tramadol Assay approved by the FDA?

ARK Tramadol Assay received FDA 510(k) clearance on 2018-12-10, under approval number K182280.

What company makes ARK Tramadol Assay?

ARK Tramadol Assay is manufactured by Ark Diagnostics, Inc..

What is the FDA product code for ARK Tramadol Assay?

The FDA product code for ARK Tramadol Assay is DJG.

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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