Cleared Special

Beta-2-Microglobulin

K161297 · Beckman Coulter Ireland, Inc. · Immunology
Jun 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K161297 is an FDA 510(k) clearance for the Beta-2-Microglobulin, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Beckman Coulter Ireland, Inc. (Co. Clare, IE). The FDA issued a Cleared decision on June 7, 2016, 29 days after receiving the submission on May 9, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K161297 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2016
Decision Date June 07, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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