Immunoglobulin G (IgG)— 510(k) K221114

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..

Clearance details

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

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