Cleared Traditional

AU BICARBONATE REAGENT

K131546 · Beckman Coulter Ireland, Inc. · Chemistry
Oct 2013
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K131546 is an FDA 510(k) clearance for the AU BICARBONATE REAGENT, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Beckman Coulter Ireland, Inc. (Brea, US). The FDA issued a Cleared decision on October 9, 2013, 133 days after receiving the submission on May 29, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K131546 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2013
Decision Date October 09, 2013
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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