Cleared Traditional

EMIT & METHOFREXATE ASSAY

K833634 · Syva Co. · Toxicology
Dec 1983
Decision
66d
Days
—
Risk

About This 510(k) Submission

K833634 is an FDA 510(k) clearance for the EMIT & METHOFREXATE ASSAY, a Enzyme Immunoassay, Methotrexate, submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983, 66 days after receiving the submission on October 17, 1983. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K833634 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1983
Decision Date December 22, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LAO — Enzyme Immunoassay, Methotrexate
Device Class —

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