Name: Predicase
Price: 199 USD

K-number	K090734
Device name	EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
Applicant	Medica Corp.
Product code	MRR
Device class	Class I
Decision date	Jul 17, 2009
Decision	Substantially Equivalent
Regulation	862.1475

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Source

View the full FDA submission: accessdata.fda.gov

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EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES

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