Cleared Traditional

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM

K131595 · Eurotrol B.V. · Chemistry
Jul 2013
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K131595 is an FDA 510(k) clearance for the EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM, 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 July 26, 2013, 53 days after receiving the submission on June 3, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K131595 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2013
Decision Date July 26, 2013
Days to Decision 53 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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