Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) 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. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K163359.

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

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

Who is the listed applicant for ARK Methotrexate 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 Assay?

The FDA product code for ARK Methotrexate 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 AssayK232017ARK Methotrexate II AssayK231752ARK Hydrocodone AssayK201089ARK Lacosamide AssayK200197ARK Fentanyl II AssayK182280ARK Tramadol Assay

View all 10 devices →

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 OperationsK232017ARK Methotrexate II 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.

↑