Name: Predicase
Price: 199 USD

K-number	K132399
Device name	ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
Applicant	Elitechgroup
Product code	JFY
Device class	Class II
Decision date	Jan 3, 2014
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL

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