Immunoglobulin G (IgG)— 510(k) K221114

Name: FDA 510(k) clearance K221114
Creator: U.S. Food and Drug Administration
Published: 2023-08-02

Substantially Equivalent

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

FDA 510(k) clearance K221114 for Immunoglobulin G (IgG), Substantially Equivalent on 2023-08-02. Applicant: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2022-04-15
Decision date: 2023-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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