Cleared Traditional

Ceruloplasmin

K161508 · Beckman Coulter Ireland, Inc. · Immunology
Jan 2017
Decision
222d
Days
Class 2
Risk

About This 510(k) Submission

K161508 is an FDA 510(k) clearance for the Ceruloplasmin, a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB), submitted by Beckman Coulter Ireland, Inc. (Co. Clare, IE). The FDA issued a Cleared decision on January 9, 2017, 222 days after receiving the submission on June 1, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.

Submission Details

510(k) Number K161508 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2016
Decision Date January 09, 2017
Days to Decision 222 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DDB — Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5210

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