K-number	K861733
Device name	ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS
Applicant	Kyoto Diagnostics, Inc.
Product code	JIL
Device class	Class II
Decision date	Jul 25, 1986
Decision	Substantially Equivalent
Regulation	862.1340

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View the full FDA submission: accessdata.fda.gov

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ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS

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