Cleared Traditional

Immunoglobulin G (IgG)

K221114 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Immunology

Aug 2023

Decision

474d

Days

Class 2

Risk

About This 510(k) Submission

K221114 is an FDA 510(k) clearance for the Immunoglobulin G (IgG), a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 2, 2023, 474 days after receiving the submission on April 15, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K221114 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2022
Decision Date	August 02, 2023
Days to Decision	474 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF