Cleared Traditional

Total Immunoglobulin E (IgE)

K220178 · Beckman Coulter, Inc. · Immunology
Mar 2022
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K220178 is an FDA 510(k) clearance for the Total Immunoglobulin E (IgE), a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on March 23, 2022, 61 days after receiving the submission on January 21, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K220178 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2022
Decision Date March 23, 2022
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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