K-number	K232027
Device name	CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
Applicant	Sebia
Product code	GKA
Device class	Class II
Decision date	Apr 4, 2024
Decision	Substantially Equivalent
Regulation	864.7415

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View the full FDA submission: accessdata.fda.gov

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CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument

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