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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-03-23 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K220178.

When did Total Immunoglobulin E (IgE) receive FDA 510(k) clearance?

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

Who is the listed applicant for Total Immunoglobulin E (IgE)?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DGC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia AB

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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