Cleared Special

ARK Methotrexate Assay

K163359 · ARK Diagnostics, Inc. · Toxicology
Aug 2017
Decision
261d
Days
—
Risk

About This 510(k) Submission

K163359 is an FDA 510(k) clearance for the ARK Methotrexate Assay, a Enzyme Immunoassay, Methotrexate, submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 18, 2017, 261 days after receiving the submission on November 30, 2016. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K163359 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2016
Decision Date August 18, 2017
Days to Decision 261 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAO — Enzyme Immunoassay, Methotrexate
Device Class —

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