Cleared Traditional

MAS IMMUNOSUPPRESSANT CONTROLS

K051074 · Microgenics Corp. · Toxicology
Jun 2005
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K051074 is an FDA 510(k) clearance for the MAS IMMUNOSUPPRESSANT CONTROLS, 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 June 6, 2005, 40 days after receiving the submission on April 27, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K051074 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2005
Decision Date June 06, 2005
Days to Decision 40 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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