Name: Predicase
Price: 199 USD

K-number	DEN200015
Device name	cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
Applicant	Roche Molecular Systems, Inc.
Product code	QLX
Device class	Class II
Decision date	Jul 30, 2020
Decision	Not Substantially Equivalent
Regulation	866.3183

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Source

View the full FDA submission: accessdata.fda.gov

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cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

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