Name: Predicase
Price: 199 USD

K-number	K182038
Device name	URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
Applicant	Yd Diagnostics Corporation
Product code	JFY
Device class	Class II
Decision date	Dec 10, 2018
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer

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