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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 the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) 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. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K232017.

When did ARK Methotrexate II Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for ARK Methotrexate II Assay?

The FDA 510(k) record lists Ark Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ark Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232522ARK Levetiracetam II AssayK231752ARK Hydrocodone AssayK201089ARK Lacosamide AssayK200197ARK Fentanyl II AssayK182280ARK Tramadol AssayK182779ARK EDDP Assay

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Related Devices (Code: LAO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233454ONLINE TDM MethotrexateRoche Diagnostics OperationsK163359ARK Methotrexate AssayArk Diagnostics, Inc.

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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