Name: Predicase
Price: 199 USD

K-number	K001885
Device name	VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	CDN
Device class	Class II
Decision date	Jul 20, 2000
Decision	Substantially Equivalent
Regulation	862.1770

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

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