Cleared Abbreviated

BICARBONATE CALIBRATOR

K141374 · Beckman Coulter Ireland, Inc. · Chemistry
Jun 2014
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K141374 is an FDA 510(k) clearance for the BICARBONATE CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Beckman Coulter Ireland, Inc. (Brea, US). The FDA issued a Cleared decision on June 30, 2014, 34 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 K141374 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2014
Decision Date June 30, 2014
Days to Decision 34 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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