Name: Predicase
Price: 199 USD

K-number	K060650
Device name	VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	LCP
Device class	Class II
Decision date	Apr 6, 2006
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702

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