Cleared Traditional

DRI OXYCODONE ASSAY

K040411 · Microgenics Corp. · Toxicology
May 2004
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K040411 is an FDA 510(k) clearance for the DRI OXYCODONE ASSAY, a Drug Specific Control Materials (Class I — General Controls, product code LAS), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on May 27, 2004, 99 days after receiving the submission on February 18, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K040411 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2004
Decision Date May 27, 2004
Days to Decision 99 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

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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