Cleared Traditional

QUANTIMETRIX NICOSURE COTININE URINE CONTROL

K062942 · Quantimetrix Corp. · Toxicology
Oct 2006
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K062942 is an FDA 510(k) clearance for the QUANTIMETRIX NICOSURE COTININE URINE CONTROL, a Drug Specific Control Materials (Class I — General Controls, product code LAS), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on October 30, 2006, 32 days after receiving the submission on September 28, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K062942 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2006
Decision Date October 30, 2006
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LAS — Drug Specific Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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