K-number	K120124
Device name	FORESIGHT U120 URINE ANALYZER
Applicant	ACON Laboratories, Inc.
Product code	JIL
Device class	Class II
Decision date	Mar 6, 2012
Decision	Substantially Equivalent
Regulation	862.1340

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Source

View the full FDA submission: accessdata.fda.gov

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FORESIGHT U120 URINE ANALYZER

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