K-number	K110583
Device name	SENSITITRE OPTIREAD
Applicant	Trek Diagnostic Systems, Ltd.
Product code	LRG
Device class	Class II
Decision date	Sep 22, 2011
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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SENSITITRE OPTIREAD

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