Cleared Abbreviated

SYSTEM CALIBRATER

K141388 · Beckman Coulter Ireland, Inc. · Chemistry
Jul 2014
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K141388 is an FDA 510(k) clearance for the SYSTEM CALIBRATER, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Beckman Coulter Ireland, Inc. (Brea, US). The FDA issued a Cleared decision on July 11, 2014, 45 days after receiving the submission on May 27, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K141388 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2014
Decision Date July 11, 2014
Days to Decision 45 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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