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FDA 510(k)

ARK Methotrexate Assay

K-Number: K163359 · 2017-08-18

ApplicantArk Diagnostics, Inc.
Decision Date2017-08-18
Product CodeLAO
DecisionSubstantially Equivalent

Device Summary

ARK Methotrexate Assay is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-08-18 under approval number K163359. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARK Methotrexate Assay?

ARK Methotrexate Assay is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K163359.

When was ARK Methotrexate Assay approved by the FDA?

ARK Methotrexate Assay received FDA 510(k) clearance on 2017-08-18, under approval number K163359.

What company makes ARK Methotrexate Assay?

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

What is the FDA product code for ARK Methotrexate Assay?

The FDA product code for ARK Methotrexate Assay is LAO.

Other Devices by Ark Diagnostics, Inc.

K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control DEN160033ARK Voriconazole II Assay Test System K182280ARK Tramadol Assay K182779ARK EDDP Assay K180427ARK Fentanyl Assay K200197ARK Fentanyl II Assay

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Related Devices (Code: LAO)

K232017ARK Methotrexate II AssayArk Diagnostics, Inc. K233454ONLINE TDM MethotrexateRoche Diagnostics Operations

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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