Name: Predicase
Price: 199 USD

K-number	DEN160019
Device name	CINtec Histology (50 tests), CINtec Histology (250 tests)
Applicant	Ventana Medical Systems, Inc.
Product code	PRB
Device class	Class II
Decision date	Mar 4, 2017
Decision	Not Substantially Equivalent
Regulation	864.1865

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Source

View the full FDA submission: accessdata.fda.gov

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CINtec Histology (50 tests), CINtec Histology (250 tests)

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