Cleared Traditional

ACA DU PONT METHOTREXATE (MTHO) METHOD

K884744 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Jan 1989
Decision
77d
Days
—
Risk

About This 510(k) Submission

K884744 is an FDA 510(k) clearance for the ACA DU PONT METHOTREXATE (MTHO) METHOD, a Enzyme Immunoassay, Methotrexate, submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on January 30, 1989, 77 days after receiving the submission on November 14, 1988. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K884744 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1988
Decision Date January 30, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LAO — Enzyme Immunoassay, Methotrexate
Device Class —

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