Cleared Traditional

CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5

K030616 · Microgenics Corp. · Toxicology
Mar 2003
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K030616 is an FDA 510(k) clearance for the CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5, 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 March 31, 2003, 33 days after receiving the submission on February 26, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K030616 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2003
Decision Date March 31, 2003
Days to Decision 33 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

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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