K-number	K183530
Device name	TruDiagnosis System
Applicant	Akonni Biosystems, Inc.
Product code	ODW
Device class	Class II
Decision date	May 24, 2019
Decision	Substantially Equivalent
Regulation	862.3360

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Source

View the full FDA submission: accessdata.fda.gov

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TruDiagnosis System

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