Name: Predicase
Price: 199 USD

K-number	K122177
Device name	ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
Applicant	Elitechgroup
Product code	JIT
Device class	Class II
Decision date	Feb 15, 2013
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL

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