Cleared Traditional

MICROGENICS CYCLOSPORINE CONTROL KIT

K032842 · Microgenics Corp. · Chemistry
Oct 2003
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K032842 is an FDA 510(k) clearance for the MICROGENICS CYCLOSPORINE CONTROL KIT, 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 October 17, 2003, 36 days after receiving the submission on September 11, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K032842 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2003
Decision Date October 17, 2003
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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