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FDA 510(k)

ARK Fentanyl Assay

K-Number: K180427 · 2018-06-06

ApplicantArk Diagnostics, Inc.
Decision Date2018-06-06
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARK Fentanyl Assay is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-06 under approval number K180427. 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 Fentanyl Assay?

ARK Fentanyl Assay is a medical device that received FDA 510(k) clearance on 2018-06-06. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K180427.

When was ARK Fentanyl Assay approved by the FDA?

ARK Fentanyl Assay received FDA 510(k) clearance on 2018-06-06, under approval number K180427.

What company makes ARK Fentanyl Assay?

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

What is the FDA product code for ARK Fentanyl Assay?

The FDA product code for ARK Fentanyl Assay is DJG.

Other Devices by Ark Diagnostics, Inc.

K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control K163359ARK Methotrexate Assay DEN160033ARK Voriconazole II Assay Test System K182280ARK Tramadol Assay K182779ARK EDDP Assay K200197ARK Fentanyl II Assay

View all 11 devices →

Related Devices (Code: DJG)

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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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