Cleared Traditional

EUROTROL GAS-ISE METABOLITES

K121468 · Eurotrol B.V. · Chemistry
Jun 2012
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K121468 is an FDA 510(k) clearance for the EUROTROL GAS-ISE METABOLITES, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on June 22, 2012, 36 days after receiving the submission on May 17, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K121468 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2012
Decision Date June 22, 2012
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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