K-number	K143333
Device name	Revital-Ox RESERT Solution Test Strip
Applicant	STERIS Corporation
Product code	JOJ
Device class	Class II
Decision date	Apr 14, 2015
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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Revital-Ox RESERT Solution Test Strip

Everything you need for a 510(k) submission. Nothing you don't.