Cleared Traditional

ARK Methotrexate II Assay

K232017 · ARK Diagnostics, Inc. · Toxicology
Dec 2023
Decision
166d
Days
—
Risk

About This 510(k) Submission

K232017 is an FDA 510(k) clearance for the ARK Methotrexate II Assay, a Enzyme Immunoassay, Methotrexate, submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on December 20, 2023, 166 days after receiving the submission on July 7, 2023. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K232017 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2023
Decision Date December 20, 2023
Days to Decision 166 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAO — Enzyme Immunoassay, Methotrexate
Device Class —

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