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FDA 510(k)

Total Immunoglobulin E (IgE)

K-Number: K220178 · 2022-03-23

ApplicantBeckman Coulter, Inc.
Decision Date2022-03-23
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Total Immunoglobulin E (IgE) is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-03-23 under approval number K220178. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Total Immunoglobulin E (IgE)?

Total Immunoglobulin E (IgE) is a medical device that received FDA 510(k) clearance on 2022-03-23. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K220178.

When was Total Immunoglobulin E (IgE) approved by the FDA?

Total Immunoglobulin E (IgE) received FDA 510(k) clearance on 2022-03-23, under approval number K220178.

What company makes Total Immunoglobulin E (IgE)?

Total Immunoglobulin E (IgE) is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Total Immunoglobulin E (IgE)?

The FDA product code for Total Immunoglobulin E (IgE) is DGC.

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Related Devices (Code: DGC)

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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.

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