Name: Predicase
Price: 199 USD

K-number	K042520
Device name	VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	KLS
Device class	Class II
Decision date	Nov 30, 2004
Decision	Substantially Equivalent
Regulation	862.3880

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III

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