Cleared Traditional

MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT

K040758 · Microgenics Corp. · Toxicology
May 2004
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K040758 is an FDA 510(k) clearance for the MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on May 28, 2004, 64 days after receiving the submission on March 25, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K040758 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2004
Decision Date May 28, 2004
Days to Decision 64 days
Submission Type Traditional
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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