Cleared Special

MODIFICATION TO PROFILE -II

K002776 · Medtox Diagnostics, Inc. · Toxicology
Sep 2000
Decision
22d
Days
—
Risk

About This 510(k) Submission

K002776 is an FDA 510(k) clearance for the MODIFICATION TO PROFILE -II, a Enzyme Immunoassay, Phencyclidine, submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on September 28, 2000, 22 days after receiving the submission on September 6, 2000. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K002776 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2000
Decision Date September 28, 2000
Days to Decision 22 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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