Total Immunoglobulin E (IgE)— 510(k) K220178

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K220178 for Total Immunoglobulin E (IgE), Substantially Equivalent on 2022-03-23. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DGC
Advisory panel: Immunology
Date received: 2022-01-21
Decision date: 2022-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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