FDA 510(k)

Immunoglobulin G (IgG)

Número K: K221114 · 2023-08-02

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

Data da decisão2023-08-02

Código do produtoCFN

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Immunoglobulin G (IgG) is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K221114. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Immunoglobulin G (IgG)?

Immunoglobulin G (IgG) is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. The 510(k) number is K221114.

When did Immunoglobulin G (IgG) receive FDA 510(k) clearance?

Immunoglobulin G (IgG) received FDA 510(k) clearance on 2023-08-02, under 510(k) number K221114.

Who is the listed applicant for Immunoglobulin G (IgG)?

The FDA 510(k) record lists Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Immunoglobulin G (IgG)?

The FDA product code for Immunoglobulin G (IgG) is CFN.

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