K-number	K192095
Device name	CAPI 3 Immunotyping, Capillarys 3 Tera
Applicant	Sebia
Product code	CFF
Device class	Class II
Decision date	Nov 1, 2019
Decision	Substantially Equivalent
Regulation	866.5510

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Source

View the full FDA submission: accessdata.fda.gov

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CAPI 3 Immunotyping, Capillarys 3 Tera

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