Cleared Traditional

Urine/CSF Albumin, Urine/CSF Albumin Calibrator

K142346 · Beckman Coulter Ireland, Inc. · Chemistry
Oct 2014
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K142346 is an FDA 510(k) clearance for the Urine/CSF Albumin, Urine/CSF Albumin Calibrator, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by Beckman Coulter Ireland, Inc. (Co. Clare, IE). The FDA issued a Cleared decision on October 15, 2014, 54 days after receiving the submission on August 22, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K142346 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2014
Decision Date October 15, 2014
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DCF — Albumin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040

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