Cleared Special

MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

K060417 · Quantimetrix Corp. · Toxicology
Mar 2006
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K060417 is an FDA 510(k) clearance for the MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on March 21, 2006, 32 days after receiving the submission on February 17, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K060417 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2006
Decision Date March 21, 2006
Days to Decision 32 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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