Name: Predicase
Price: 199 USD

K-number	K082811
Device name	URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
Applicant	Urit Medical Electronic Co., Ltd.
Product code	JIO
Device class	Class II
Decision date	Sep 11, 2009
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS

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