Immunoglobulin G (IgG)
K-Number: K221114 · 2023-08-02
Decision Date2023-08-02
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Immunoglobulin G (IgG) is a medical device manufactured by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-08-02 under approval number K221114. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Immunoglobulin G (IgG)?
Immunoglobulin G (IgG) is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. The 510(k) number is K221114.
When was Immunoglobulin G (IgG) approved by the FDA?
Immunoglobulin G (IgG) received FDA 510(k) clearance on 2023-08-02, under approval number K221114.
What company makes Immunoglobulin G (IgG)?
Immunoglobulin G (IgG) is manufactured by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd..
What is the FDA product code for Immunoglobulin G (IgG)?
The FDA product code for Immunoglobulin G (IgG) is CFN.
Other Devices by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.