Cleared Abbreviated

CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500

K080183 · Roche Diagnostics Corp. · Chemistry
Mar 2008
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K080183 is an FDA 510(k) clearance for the CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 25, 2008, 60 days after receiving the submission on January 25, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K080183 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2008
Decision Date March 25, 2008
Days to Decision 60 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
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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