K-number	K220178
Device name	Total Immunoglobulin E (IgE)
Applicant	Beckman Coulter, Inc.
Product code	DGC
Device class	Class II
Decision date	Mar 23, 2022
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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Total Immunoglobulin E (IgE)

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