Cleared Traditional

ONLINE TDM Methotrexate

K233454 · Roche Diagnostics Operations · Toxicology
Feb 2024
Decision
123d
Days
—
Risk

About This 510(k) Submission

K233454 is an FDA 510(k) clearance for the ONLINE TDM Methotrexate, a Enzyme Immunoassay, Methotrexate, submitted by Roche Diagnostics Operations (Indianapolos, US). The FDA issued a Cleared decision on February 20, 2024, 123 days after receiving the submission on October 20, 2023. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K233454 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2023
Decision Date February 20, 2024
Days to Decision 123 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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