Cleared Special

K002776 - MODIFICATION TO PROFILE -II (FDA 510(k) Clearance)

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

K002776 is an FDA 510(k) clearance for the MODIFICATION TO PROFILE -II. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number K002776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 —