Name: Predicase
Price: 199 USD

K-number	K050119
Device name	PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
Applicant	Beckman Coulter, Inc.
Product code	JKM
Device class	Class II
Decision date	May 6, 2005
Decision	Substantially Equivalent
Regulation	866.5150

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Source

View the full FDA submission: accessdata.fda.gov

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PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT

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