K-number	DEN200044
Device name	Eonis SCID-SMA Kit
Applicant	Perkinelmer, Inc.
Product code	QUE
Device class	Class II
Decision date	Nov 9, 2022
Decision	Not Substantially Equivalent
Regulation	866.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Eonis SCID-SMA Kit

Everything you need for a 510(k) submission. Nothing you don't.