K-number	K213403
Device name	Aptiva CTD Essential Reagent
Applicant	Inova Diagnostics, Inc.
Product code	LLL
Device class	Class II
Decision date	Sep 29, 2023
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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Aptiva CTD Essential Reagent

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