K-number	K162378
Device name	FREND PSA PLUS (reagent cartridge)
Applicant	Nanoentek USA, Inc.
Product code	LTJ
Device class	Class II
Decision date	May 17, 2017
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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FREND PSA PLUS (reagent cartridge)

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