Name: Predicase
Price: 199 USD

K-number	K212427
Device name	cobas Cdiff nucleic acid test for use on the cobas Liat System
Applicant	Roche Molecular Systems, Inc.
Product code	OZN
Device class	Class II
Decision date	Oct 20, 2021
Decision	Substantially Equivalent
Regulation	866.3130

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Source

View the full FDA submission: accessdata.fda.gov

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cobas Cdiff nucleic acid test for use on the cobas Liat System

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