K-number	K231151
Device name	Kenota 1 Total IgE; Kenota 1 (instrument)
Applicant	Kenota, Inc.
Product code	DGC
Device class	Class II
Decision date	May 31, 2024
Decision	Substantially Equivalent
Regulation	866.5510

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Source

View the full FDA submission: accessdata.fda.gov

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Kenota 1 Total IgE; Kenota 1 (instrument)

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