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FDA 510(k)

ARK Methotrexate II Assay

K-Number: K232017 · 2023-12-20

ApplicantArk Diagnostics, Inc.
Decision Date2023-12-20
Product CodeLAO
DecisionSubstantially Equivalent

Device Summary

ARK Methotrexate II Assay is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-12-20 under approval number K232017. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARK Methotrexate II Assay?

ARK Methotrexate II Assay is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K232017.

When was ARK Methotrexate II Assay approved by the FDA?

ARK Methotrexate II Assay received FDA 510(k) clearance on 2023-12-20, under approval number K232017.

What company makes ARK Methotrexate II Assay?

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

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

The FDA product code for ARK Methotrexate II Assay is LAO.

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 K180427ARK Fentanyl Assay

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Related Devices (Code: LAO)

K163359ARK Methotrexate 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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