K-number	K170118
Device name	Scanostics UTI Check Application Test System
Applicant	Teco Diagnostics
Product code	JMT
Device class	Class I
Decision date	Sep 21, 2017
Decision	Substantially Equivalent
Regulation	862.1510

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Source

View the full FDA submission: accessdata.fda.gov

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Scanostics UTI Check Application Test System

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